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Reprocessed General & Plastic Surgery Laparoscope,Reprocessed Non-Electric Biopsy Forceps Suppliers & Manufacturers

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Reprocessed General & Plastic Surgery Laparoscope (FDA Code: NLM / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Northeast Scientific, Inc., Sterilmed, Inc., Medisiss, more...

Reprocessed Non-Electric Biopsy Forceps (FDA Code: NON / 876.1075)

Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Sterilmed, Inc., Medisiss, Stryker Trauma Gmbh

Reprocessed Urological Active Electrosurgical Electrode (FDA Code: NLW / 876.43)

Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Classification. Class II (performance standards).

Sterilmed, Inc.

Resection Electrodes
Gyrus ACMI, C. r. Bard, Inc., Gyrus Group PLC, more...

Resectoscope Working Element (FDA Code: FDC / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Vyaire Medical, Inc., DePuy Orthopaedics, Inc, Gyrus ACMI, more...

Resectoscopes (FDA Code: FJL / 876.15)
Resectoscopes are used for conducting surgery in body cavities. Resectoscopes are used for transurethral and gynecological surgical procedures. Resectoscopes include a handle, a telescope for viewing the surgical site and an electrode assembly, which is used for performing surgical procedures.

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

Gyrus ACMI, Stryker, Olympus America, Inc., more...

Retention Type Catheter (FDA Code: EZK / 876.598)

Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures in subpart E of this part subject to the limitations in 876.9.

Cook Group Incorporated, E-Z-EM Inc., Smiths Medical Deutschland GmbH, more...

Reusable Biopsy Forceps
Rusch Inc., Autosuture, High Class Dental, more...

Reusable Hook Cautery Instruments
Reusable hook cautery instruments include laparoscopic instrument, reusable insert, protective insert, protective shield, primary insulation layer, outer insulation, and active electrode element. The protective shield built provides a neutral return path for capacitively coupled energy and protection from insulation failure. The shield is continuously monitored during surgery which provides continuous assurance of the integrity of the instrument.
Cambrian Medical Inc., Encision Inc., Valleylab, more...

Reusable Latex Leg Bag
Reusable latex leg bag offers odor protection. It has a fast-draining anti-reflux red valve and an anatomical loop suspensory for the most comfortable and discreet fit. Its offset port design permits unrestricted flow in the seated position.
Mentor Corporation, Best Buy Care Supplies, Inc., Hollister Incorporated, more...

Reusable Obturators
Gyrus ACMI, Cannuflow Incorporated (CFI), Medit Inc

Reusable Thermal Cautery Electrodes
Cambrian Medical Inc., Advanced Meditech International, Inc.

Ribdam (FDA Code: EYS / 876.456)

Identification. A ribdam is a device that consists of a broad strip of latex with supporting ribs used to drain surgical wounds where copious urine drainage is expected.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 876.9.

General Surgical Co., (india) Pvt. Ltd., Lifecare Surgical

Rigid Cystoscopes
Rigid cystoscopy is an examination of the bladder using an instrument called a cystoscope. This device has a light on the end, which enables the doctor to see as he/she looks through the urethra to bladder. During this procedure the doctor can scrape bladder tumors from the bladder wall, and/or insert stents and/or make an incision in a stricture in the bladder neck.
Gyrus ACMI, Stryker, Pentax Medical Company, more...

Rigid Gastroscope
Treier Endoscopie AG

Rigid Nephroscope
Karl Storz GmbH & Co. KG.

Rigid Rod Penis Prosthesis (FDA Code: FTQ / 876.363)

Identification. A penile rigidity implant is a device that consists of a pair of semi-rigid rods implanted in the corpora cavernosa of the penis to provide rigidity. It is intended to be used in men diagnosed as having erectile dysfunction.

Classification. Class II. The special control for this device is the FDA guidance entitled "Guidance for the Content of Premarket Notifications for Penile Rigidity Implants."

Timm Medical Technologies, Inc.

Rigid Self-Opening Snare (FDA Code: FDJ / 876.43)

Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Classification. Class II (performance standards).

Aesculap Inc., Cathguide, Cameron-Miller, Inc., more...

Rob-nel Catheters
Rob-Nel catheter is sterile and has thermo-sensitive polyvinyl chloride(PVC), smooth rounded tip, integral tapered funnel end and two staggered eyes.
Cardinal Health, Inc., Duraline Medical Products, Inc.

Robinson Catheters
Robinson catheter is used for intermittent catheterization of a male or female patient to provide drainage of urine from the bladder. It is intended for one-time use.
Cardinal Health, Inc.

Rotating Continuous Flow Resectoscopes
Rotating Continuous Flow Resectoscopes feature rotating design, continuous flow, snap-in snap-out locking mechanisms, quick release button for electrode, snap-on active cord, ergonomic handle grip configuration and color-coded sheaths & obturators.
Gyrus ACMI, Stryker, Richard Wolf Medical Instruments Corp., more...

Rotating Oval Specimen Forceps
AHM International Surgical, Nopa Instruments Medizintechnik Gmbh

Routine Fiberoptic Light Source (FDA Code: FCW / 876.15)

Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Classification. (1) Class II (performance standards).

TTI Medical, Marina Medical Instruments Inc., Elmed Inc., more...

Scalpel Vasectomy Hemostat
Miltex, Inc., MYCO Medical

Scrotal Support
SAI Therapeutic Brands, A-T Surgical Mfg. Co., Inc.

Sealed Dialysate Delivery System (FDA Code: FII / 876.586)

Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:

Classification. Class II. The special controls for this device are FDA's:

Fresenius Medical Care North America

Self-Adhering External Catheters
Alsius Corporation, Mentor Corporation, Anthony Products, Inc., more...

Self-Retaining Retractors (FDA Code: FFO / 876.473)

Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 876.9.

Van Nuys Group of Industries, Southpointe Surgical Supply, Inc., Medtronic Xomed Surgical Products, Inc, more...

Semi Automated Urine Chemistry Analyzer
Semi automated urine chemistry analyzer is a single sample benchtop instrument for low-to-moderate urine testing. It is designed to perform like no other urinalysis system. It's the instrument solution that eliminates the tradeoffs between performance and value.
Becton, Dickson & Co.,, Globe Scientific Inc., Medical Sales & Service

Semi Rigid biopsy forceps
Rusch Inc., Autosuture, High Class Dental, more...

Semi Rigid Fiberoptic Ureteroscopes
Gyrus ACMI

Semi-Automatic Peritoneal Dialysate Delivery System (FDA Code: KPF / 876.563)

Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.

Classification. Class II (performance standards).

Baxter Healthcare Corp., Renal Division, Baxter International Inc, Erika De Reynosa, S.A. De C.V., more...

Semi-Rigid Ureteroscopes
Semi-Rigid Ureteroscopes features one-piece tapered conical shaft for gradual, atraumatic ureteral dilation, autoclavable high density fused quartz bundle provide rod lens-like high resolution image, dual working channels and ergonomic working channel placement & finger holds for surgeon control.
Gyrus ACMI, Stryker, Stryker Endoscopy, more...

Semi-Rigid Ureterscopes
Semi Rigid Ureteroscopy is used to access the ureter below the iliac vessels, so that various lithotripsy options are available for fragmenting stones.
Cortekr Endoscopy, Inc., Gyrus ACMI

Semiautomated Urinalysis Systems
Roche Corporate, Sysmex Corporation

Sengstaken Esophageal Tube
Hood Laboratories

Shockwave Lithotripsy Systems
Gyrus ACMI, Siemens Medical Solutions USA Inc, Elmed Electronics & Medical Industry & Trade Inc.

Shunt Adaptor (FDA Code: FKN / 876.554)

Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Classification. (1) Class III (premarket approval) for the implanted blood access device.

Codman & Shurtleff, Inc., Angiodynamics, Inc., Schmidt-Medizintechnik GmbH

Shunt Connector (FDA Code: FJQ / 876.554)

Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Classification. (1) Class III (premarket approval) for the implanted blood access device.

Apothecary Products, Inc., Angiodynamics, Inc., Microcision LLC

Shunt Guard (FDA Code: FJM / 876.554)

Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Classification. (1) Class III (premarket approval) for the implanted blood access device.

Kuraray Kurashiki Plant

Sialoglycoprotein Catheter
Ranfac Corp.

Silicone Coated Twoway Foley Catheters
Cardinal Health, Inc., WyMedical Ltd, Jiaxing U-Life Medical Device Technology Co., Ltd.

Silicone Elastomer, Coated Latex Foley Catheters
Southwest Medical, Cardinal Health, Inc., Amsino International, Inc, more...

Silicone Elastomer-Coated Latex Foley Catheters
Alsius Corporation, Adinstruments, Inc, Rochester Medical Corporation, more...

Silicone Foley Catheters
Mentor Corporation, KCK Medical, Medical Department Store, more...

Silicone Pediatric Foley Catheter
Silicone pediatric foley catheter is a double lumen, straight-tip catheter, which allows drainage of urine through one lumen while the second lumen leads to a balloon that is filled with water. This balloon secures the tube in the bladder.
Mentor Corporation, Cardinal Health, Inc.

Silicone Penrose Drainage Tube
Bentec Medical,Inc., Cook Group Incorporated, Zimmer, Inc., more...

Silicone Penrose Drains
Taut, Inc., Hanson Medical Inc, Struba Gummi AG, more...

Silicone T-Y Drainage Tube
Bentec Medical,Inc., Cook Group Incorporated, Zimmer, Inc., more...

Silicone Y-Drainage Tube
Bentec Medical,Inc., Cook Group Incorporated, Zimmer, Inc., more...

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