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Mechanical/Hydraulic Impotence Device,Mechanical/Hydraulic Incontinence Device Suppliers & Manufacturers

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Mechanical/Hydraulic Impotence Device (FDA Code: FHW / 876.335)

Identification. A penile inflatable implant is a device that consists of two inflatable cylinders implanted in the penis, connected to a reservoir filled with radiopaque fluid implanted in the abdomen, and a subcutaneous manual pump implanted in the scrotum. When the cylinders are inflated, they provide rigidity to the penis. This device is used in the treatment of erectile impotence.

Classification. Class III (premarket approval).

Laserscope, Bio-Feedback Systems, Inc., Encore, Inc., more...

Mechanical/Hydraulic Incontinence Device (FDA Code: EZY / 876.528)

Identification. An implanted mechanical/hydraulic urinary continence device is a device used to treat urinary incontinence by the application of continuous or intermittent pressure to occlude the urethra. The totally implanted device may consist of a static pressure pad, or a system with a container of radiopaque fluid in the abdomen and a manual pump and valve under the skin surface that is connected by tubing to an adjustable pressure pad or to a cuff around the urethra. The fluid is pumped as needed from the container to inflate the pad or cuff to pass on the urethra.

Classification. Class III (premarket approval).

Laserscope, Neurodyne Medical Corp., Accellent Inc., more...

Membrane Automated Blood Cell/Plasma Separator For Therapeutic Purposes (FDA Code: MDP)
Cytori Therapeutics Inc, Oita Works, Asahi Kasei Kuraray Medical Co., Ltd.

Metal Mesh (FDA Code: EZX / 878.33)

Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Classification. Class II.

Nuvasive Inc., Medtronic Xomed Surgical Products, Inc, Zimmer, Inc., more...

Metal Surgical Clips
Metal Surgical Clips are used in head and neck surgery. The use of metal surgical clips requires minimal dissection. Metal surgical clips are used to close wounds after surgery.
Kroslak Enterprises, Inc., Cook Urological, Advanced Meditech International, Inc., more...

Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.468)

Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

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

Edwards Lifesciences Corporation, Advanced Bionics Corporation, Vyaire Medical, Inc., more...

Metal-tipped Push Catheters
Metal-tipped push catheters are used to induce a propulsive contraction, which tended to push feces toward the anus. It produces larger radiofrequency lesions through tip cooling, abstract and circulation.
Cardinal Health, Inc.

Metal/Plastic Urethral Sound (FDA Code: FBX / 876.552)

Identification. A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

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

Nihon Kohden America, Inc., Sontec Instruments, Inc., KLS Martin, L.P., more...

Metallic Ureteral Stent Set
Cook Group Incorporated, Cook Urological, American Medical Systems, more...

Mick Applicator TP Prostate Implant Seeding Needles
Medical Supplies & Equipment Company LLC, MYCO Medical

Micro Castroviejo Needle Holder with Stopper
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Micro Needle Holders with Flat Handles
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Micro Needle Holders with Lightweight Plastic Handles
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Micro Spring Handle Needle Holder
ArosurgicalT Instruments Corporation, Marina Medical Instruments Inc., Elmed Inc., more...

Microplate Analyzer, Multilabel Reader
Becton, Dickson & Co.,, Bmg Labtech GmbH, Sunostik Medical Technology Co., Ltd.

Microvascular Needle Holders
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Microwave Hyperthermia System (FDA Code: MEQ)
Laserscope, Advanced Bionics Corporation, Celsion Corporation, more...

Microwave Thermotherapy (TUMT) Systems
Microwave Thermotherapy Systems are used for benign prostatic hyperplasia treatment, which operate with urethral or rectal applicator. Microwave thermotherapy systems are intended to heat the prostate, resulting in the necrosis of periurethral prostatic tissue.
Gyrus ACMI, Urologix, Inc., American Medical Systems, more...

Microwave Treatments, Cooled Thermotherapy
Gyrus ACMI

Midstream Catch Kits
Midstream Catch Kits feature a moisture resistant plastisol liner that minimizes chance of leakage, clear packaging and pneumatic capable with castile soap towelettes.
Covidien

Midstream Clean-Catch Urine Samples Kits
Focus Diagnostics, Inc.

Miller-Abbott Gastrointestinal Decompression Tube
Andersen Products, Inc.

Mini Cystoscopes
Gyrus ACMI, Stryker, Pentax Medical Company, more...

Mini-Diameter Choledochoscope
Olympus America, Inc.

Miniature Light Guides
Gyrus ACMI, Medical Supplies & Equipment Company LLC, Mazor Surgical Technologies

Minimally Invasive BPH Therapies
Gyrus ACMI, Medtronic Ophthalmics, Nico Corporation, more...

Minimally Invasive BPH Treatment Device
Gyrus ACMI, Intermed Japan, Inc.

Miscellaneous Endoscope Bulb Adaptor (FDA Code: FFY / 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).

Advanced Sterilization Products, Advanced Bionics Corporation, Marina Medical Instruments Inc., more...

Mobile Urology Imaging System
HealthTronics, Inc.

Molecular Adsorbent Recirculating System (Mars) (FDA Code: NKL)
Gambro

Monopolar Flexible Bugbee Electrodes
Urotech Devices

Multi Detection Microplate Reader
Multi Detection Microplate Reader uses a dual-optics design for fluorescence, absorbance and luminescence measurements. Multi-detection microplate reader performs an unlimited number of microplate-based assays. It combines filter-based and quadruple monochromator-based fluorescence detection technology.
Molecular Devices, Awareness Technology, Inc., Becton, Dickson & Co.,, more...

Multi-Flex Open Tip Urethral Stent Kit
Gyrus ACMI

Multi-Label Microplate Readers
Molecular Devices, Awareness Technology, Inc., Perkinelmer, Inc., more...

Multi-length Ureteral Stents
Multi-length urethral stent is designed hollow tube, which is made of a flexible plastic material that is placed in the ureter, between the kidney and the bladder. This is placed there in order to temporarily relieve the obstruction. The length of the stent used in adult patients varies between 24 to 30 cm.
Cook Group Incorporated, American Medical Systems, Cardinal Health, Inc., more...

Multi-Length Urethral Stents
Cook Urological, Bard Electrophysiology, Gyrus ACMI

Multifunctional Lithotripsy System
Siemens Medical Solutions USA Inc

Multiple Endo Clip Applier With Titanium Clips
Kroslak Enterprises, Inc., Medicon eG

Multipurpose Catheter Adapter
Catheter adapter is utilized to allow easy access to the catheter and introduction of fluid into the nerve of the patient through the catheter tip.
Hospira, Inc., Becton, Dickson & Co.,, Medical Action Industries Inc., more...

Multipurpose Lithotriptor
Storz Medical AG, Storz Medical Italia Srl, Dornier MedTech GmbH

Mushroom Catheter
B. Braun Melsungen AG

Narrow Band Spectrum Endoscope Accessories (FDA Code: NWB / 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).

Fuji Systems Corporation, Olympus Imaging Corporation, Olympus Winter & Ibe Gmbh, more...

Nasobiliary Drain
Redi-tech Medical Products Inc

Needle Holder For 10mm Diameter Tubes
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Needle Holders Repair Service
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Needle Holders with TC-Inserts
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Needle Holders with Tungsten Carbide Inserts
Marina Medical Instruments Inc., Elmed Inc., Akorn, Inc., more...

Needle Loading and Handling
Medtec, C. r. Bard, Inc.

Needle Shielding
North American Scientific, Inc., Medtec, C. r. Bard, Inc.

Needle Suspension
Cook Urological, Medical Plastic Devices (MPD) Inc.

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