ISPG,
Medovations, Inc.,
ATC Technologies, Inc.,
more...
(FDA Code:
MCX)
Abbott Vascular Devices,
Advanced Bionics Corporation,
Minnetronix, Inc.,
more...
(FDA Code:
MCW /
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).
Edwards Lifesciences Corporation,
Abbott Vascular Devices,
Bacchus Vascular,
more...
Roboz Surgical Instrument Co., Inc.,
Aspen Surgical Products,
Scanlan International,
more...
Biomedical Research Instruments, Inc.,
Nectar International,
Hilbro Private Limited,
more...
Nectar International,
Hilbro Private Limited,
ModMed Instruments,
more...
SurgiExpert,
Ancon Group of Industries,
Fame Devices Corporation,
more...
Sklar Instruments
Elmed Inc.,
Zimmer, Inc.,
Roboz Surgical Instrument Co., Inc.,
more...
Atrial/Ventricular Passive Fixation is suited for thinner atrial tissue. It features discrete electrode for consistent sensing & pacing and straight breakaway chest needle diameter reduced from 1.00 mm to 0.86 mm minimizes trauma during lead insertion.
Vascomed
(FDA Code:
MCU)
American Audio-Medical, Inc.
Kaisers Surgical Instruments Pty Ltd
Haemonetics Corporation
Haemonetics Corporation
Automated external defibrillator is a portable electronic device that automatically diagnoses the potentially life threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient and is able to treat them by application of electrical therapy which stops the arrhythmia, allowing the heart to re-establish an effective rhythm. It is designed to be simple to use for the layman, and the use of AEDs is taught in many first aid, first responder and basic life support (BLS) level CPR classes.
AED USA,
The V Bravo Company,
Soma Technology, Inc.,
more...
JIT4You, Inc.,
Nihon Kohden America, Inc.,
A&D Medical,
more...
Automatic chest, Compression systems provide optimum head hyperextension, open airway, and a firm compression surface. It makes endotracheal intubation easier. It offers automated and perfect chest compressions. It minimizes risk of CPR induced trauma. It need not be removed for defibrillation or monitoring. It also allows ambulance personnel to perform care on patient with safety restraints during transport. The constant-flow ventilator can be adjusted for desired chest rise.
Revivant Corporation,
Michigan Instruments, Inc.,
Physio Control, Inc.,
more...
Nutramax Products, Inc.
Automatic defibrillators are portable automatic device used to restore normal heart rhythm to patients in cardiac arrest. It is used to treat cardiac arrest. It is a life-saving device because cardiac arrest is a sudden condition that is fatal if not treated within a few minutes.
AED USA,
Soma Technology, Inc.,
Bristol Med Wholesale,
more...
(FDA Code:
MKJ /
870.531)
Identification. An automated external defibrillator (AED) is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. An AED analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.
Classification. Class III (premarket approval)
AED USA,
Defibrillator.net, LLC,
DRE, Inc.,
more...
Automatic Implantable Cardioverter Defibrillator is known as an ICD, which continuously monitors the heart for any rapid and/or irregular heart rhythm. When the AICD detects an arrhythmia, it delivers therapy to the heart automatically. The AICD is implanted on the left or right upper portion of the chest muscle just below the collarbone. It is mainly used to treat two forms of abnormal heart rhythms, both of which occur in the ventricles or lower pumping chambers of the heart.
Zoll Medical,
Medtronic Ophthalmics,
Cardiac Science, Inc.,
more...
(FDA Code:
NIK)
Medtronic Xomed Surgical Products, Inc,
St. Jude Medical, Inc.,
Guidant Puerto Rico B.V.,
more...
(FDA Code:
LWS)
Medtronic Xomed Surgical Products, Inc,
Medtronic, Inc.,
St. Jude Medical, Inc.,
more...
Datascope Corp.,
Welch Allyn, Inc.,
SunTech Medical,
more...
(FDA Code:
DRP /
870.5925)
Identification. An automatic rotating tourniquet is a device that prevents blood flow in one limb at a time, which temporarily reduces the total blood volume, thereby reducing the normal workload of the heart.
Classification. Class II (performance standards).
Zimmer, Inc.
(FDA Code:
MPD /
870.53)
Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.
Classification. Class II (performance standards).
AD Elektronik Gmbh
(FDA Code:
OCH /
870.27)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.
Classification. Class II (performance standards).
Beijing Choice Electronic Technology Co.,Ltd.
The balloon catheter is usually inserted percutaneously through the femoral artery. These are used for temporary occlusion of large vessels, or to expand vascular prostheses. When a balloon catheter is used to compress plaque within a clogged coronary artery it is referred to as a plain old balloon angioplasty. These are also utilized in the deployment of stents during angioplasty. When the cardiologist subsequently deflates the balloon the stent stays behind in the artery and the balloon catheter can be removed. Stents that are used in conjunction with a balloon catheter are known as balloon expandable stents.
Vitae Core,
Edwards Lifesciences Corporation,
Alsius Corporation,
more...
B. Braun Medical Inc.
(FDA Code:
MAV /
870.165)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.
Classification. Class II (performance standards).
Abbott Vascular Devices,
Advanced Bionics Corporation,
Medtronic Xomed Surgical Products, Inc,
more...
Oscor Inc.,
Cook Group Incorporated,
Arrow International, Inc.,
more...
Zoll Medical,
Welch Allyn, Inc.,
Laerdal Medical Corp,
more...
Nihon Kohden America, Inc.,
Zoll Medical,
Datascope Corp.,
more...
Boston Scientific Corporation,
Accellent Inc.,
Guidant Corporation
Elmed Inc.,
Medical Graphics Corporation,
Cardiac Science, Inc.,
more...
W. l. Gore & Associates, Inc.,
Bard Japan Ltd.
Polymerex Medical Corp.,
Abbott Laboratories,
Boston Scientific Corporation,
more...
Cryolife Inc.
(FDA Code:
DYE /
870.3925)
Identification. A replacement heart valve is a device intended to perform the function of any of the heart's natural valves. This device includes valves constructed of prosthetic materials, biologic valves (e.g., porcine valves), or valves constructed of a combination of prosthetic and biologic materials.
Classification. Class III (premarket approval).
Edwards Lifesciences Corporation,
Medtronic Xomed Surgical Products, Inc,
Cryolife Inc.,
more...
Organogenesis Inc.,
Hancock Jaffe Laboratories,
Boston Scientific Corporation,
more...
(FDA Code:
DRR /
870.205)
Identification. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.
Classification. Class II (performance standards).
Diagnostic Automation, Inc.,
Biocheck, Inc.,
Biomerica,
more...
Pulmonary valved conduit is a bioprosthetic heart valve made from a segment of cow (bovine) jugular vein. It is treated with preservatives to keep it durable, flexible and sterilized for human implantation. It is used to correct or reconstruct the outflow of the right ventricle in the congenital heart malformations like narrowing of the pulmonary valve and one heart artery forms both the aorta & pulmonary artery.
Medtronic, Inc.,
Hancock Jaffe Laboratories
Edwards Lifesciences Corporation,
Carbomedics Inc.,
ATS Medical, Inc.,
more...
Edwards Lifesciences Corporation,
Carbomedics Inc.,
Sorin Biomedica Cardio S.p.A.
Cordis Corp.,
Cook Group Incorporated,
Fujinon, Inc.,
more...
Cordis Corp.,
Cook Group Incorporated,
Fujinon, Inc.,
more...
Rusch Inc.,
Autosuture,
High Class Dental,
more...
Biphasic defibrillators are deliver shock in two directions, from one paddle to the other, then the current reverses direction. Biphasic waveforms decrese the threshold for successful defibrillation. This means biphasic defibrillators are more effective than monophasic defibrillatos and use less electrical energy to defibrillate or cardiovert. Using less electrical energy results in less postshock myocardial dysfunction and a lower risk of skin burns.
DRE, Inc.,
Principal Medical LLC,
Cardiac Science, Inc.,
more...
Alsius Corporation,
Venetec International, Inc.
Bipolar pacing catheters are designed for temporary right ventricular endocardial pacing. It has a pair of electrodes at the tip that provide capabilities for bipolar pacing. It is suitable for use in temporary and transvenous right ventricular pacing.
Alsius Corporation,
Biosensors International USA,
Venetec International, Inc.,
more...