Hoa International,
Kaisers Surgical Instruments Pty Ltd
Colonial/Han-Dee Spring, LLC,
Containmed, Inc.,
Orthomechanics, L.C.,
more...
Medtronic MiniMed, Inc.,
Med-Choice,
Applied Diabetes Research, Inc.,
more...
Welch Allyn, Inc.
Welch Allyn, Inc.
Patterson Medical Products, Inc.,
ConvaTec Inc.,
Chattanooga Group
(FDA Code:
MTE)
St. Jude Medical, Inc.,
EP Medsystems, Inc.,
Medtronic Ablation Frontiers LLC
Sophysa USA, Inc.,
Lemaitre Vascular, Inc.
An internal defibrillator is a small device implanted under the skin. It measures the electrical activity of the heart and delivers a therapy shock if a dangerously fast heart rhythm is detected. It automatically monitor heart rhythm and deliver therapy as needed to prevent sudden cardiac arrest. An implantable defibrillator can first use small painless electrical signals to correct heart rate.
AED USA,
Cardiac Science, Inc.,
Philips Medical Systems, N.A.,
more...
Cardima, Inc.
Cardima, Inc.
Cardima, Inc.
Cardima, Inc.
Cardima, Inc.
Cardima, Inc.
M&i Medical Sales, Inc.,
QRS Diagnostic,
Midmark Corporation,
more...
Welch Allyn, Inc.
Mortara Instrument, Inc.,
Seiva s.r.o.
Kaisers Surgical Instruments Pty Ltd
Datascope Corp.,
Arrow International, Inc.,
Arrow International, Inc,
more...
Datascope Corp.,
Kontron Medical
Intra-Aortic Balloon Pumps are used to facilitate arterioarterial pumping. Intra-aortic balloon pumps consist of an elastomeric balloon that is pneumatically driven and controlled to raise central aortic pressure soon after left ventricular ejection & aortic valve closure. This reduces the workload of the heart. These are inserted percutaneously into the aorta via a femoral artery. Intra-aortic balloon pumps are used in refractory cardiac failure as a bridge to surgery.
Soma Technology, Inc.,
Bristol Med Wholesale,
DRE, Inc.,
more...
Datascope Corp.,
Octopus Medical Technologies P. Ltd.
(FDA Code:
DSP /
870.3535)
Identification. A intra-aortic balloon and control system is a device that consists of an inflatable balloon, which is placed in the aorta to improve cardiovascular functioning during certain life-threatening emergencies, and a control system for regulating the inflation and deflation of the balloon. The control system, which monitors and is synchronized with the electrocardiogram, provides a means for setting the inflation and deflation of the balloon with the cardiac cycle.
Classification. Class III (premarket approval).
DRE, Inc.,
Abiomed, Inc.,
Datascope Corp.,
more...
Ranfac Corp.,
Popper & Sons Inc
Biosense Webster, Inc.
Biosense Webster, Inc.
Sunrise Medical,
Medovations, Inc.,
Armm, Inc.,
more...
(FDA Code:
DXW /
870.127)
Identification. An intracavitary phonocatheter system is a system that includes a catheter with an acoustic transducer and the associated device that processes the signal from the transducer; this device records bioacoustic phenomena from a transducer placed within the heart, blood vessels, or body cavities.
Classification. Class II (performance standards).
Millar Instruments, Inc.
(FDA Code:
DWX /
870.4875)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)
Classification. Class II (performance standards).
Vyaire Medical, Inc.,
Cook Group Incorporated,
Scanlan International,
more...
(FDA Code:
ORD /
870.12)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Classification. Class II (performance standards).
Lightlab Imaging,I nc.
Alsius Corporation,
Anthony Products, Inc.,
Venetec International, Inc.
(FDA Code:
MOU)
Best Vascular, Inc.,
Boston Scientific Corporation
Koga Isotope Co., Ltd.
Koga Isotope Co., Ltd.
Cordis Corp.
(FDA Code:
OBJ /
870.12)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.
Classification. Class II (performance standards).
Biosense Webster, Inc.,
Volcano Corporation,
VasoNova, Inc.,
more...
(FDA Code:
DPW /
870.21)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.
Classification. Class II (performance standards).
Nihon Kohden America, Inc.,
Edwards Lifesciences Corporation,
Volcano Corporation,
more...
Intravenous catheters are used to reduce accidental needle sticks without requiring user activation. It is usually inserted to deliver fluids and medications when a patient is unable to receive them orally. It consists of a needle and a plastic sheath, is inserted through skin into the vein. Once in the vein, the plastic catheter is advanced further and the metal needle is withdrawn and the rubber band is released. It is then connected to plastic tubing and small amount of fluid is given through the catheter to confirm the correct placement. Then this whole system is secured with tape and dressing.
Alsius Corporation,
Exel International Medical Products,
Diablo Sales & Marketing, Inc.,
more...
Sedat
Bracco Diagnostics Inc.
The Smartpill Corporation
Oscor Inc.,
Remington Medical, Inc.,
Caldera Medical,
more...
Datascope Corp.,
Siemens Medical Solutions USA Inc,
Mennen Medical Corp.,
more...
ISPG,
Medovations, Inc.,
ATC Technologies, Inc.,
more...
IV Catheter is intended to reduce accidental needle sticks without requiring user activation. It is usually inserted to deliver fluids and medications when a patient is unable to receive them orally. It consists of a needle and a plastic sheath, is inserted through skin into the vein. Once in the vein, the plastic catheter is advanced further and the metal needle is withdrawn and the rubber band is released. The IV catheter is then connected to plastic tubing and small amount of fluid is given through the catheter to confirm the correct placement. Then this whole system is secured with tape and dressing.
Alsius Corporation,
Exel International Medical Products,
Medical Supply Group,
more...
IVUS catheters are tiny medical devices that, when inserted into a person's coronary arteries, reflect images from inside the coronary arteries to an attached console so that cardiologists can observe the location and amount of damage to the arteries from cholesterol buildup and other diseases. Cardiologists need this information for diagnostic and treatment purposes.
Volcano Corporation,
Siemens Medical Solutions USA Inc,
Venetec International, Inc.
Alsius Corporation,
Volcano Corporation,
Venetec International, Inc.
IVUS console is a computing device used to deploy IVUS catheters and to convert into display images signals transmitted by IVUS catheters. It is electrically connected to a catheter and acquires RF backscattered data from a vascular structure.
Volcano Corporation
Volcano Corporation,
Carrot Medical