12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RESPOND(R) Ventilator
FDA 510(k)
FDA Class 2
·Anesthesiology
Pomee
FDA UDI
POMEE CORPORATION·G15772411350·Kelly forceps 5 1/2" curved
TOTAL MANDIBULAR SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036062774·
J & J INSTRUMENTS
FDA UDI
J & J INSTRUMENTS INC·00817524026047·KELLY FCP 5.5"" CVD
Sochi
FDA UDI
Altus Spine, LLC·00843210168548·Screw Offset, Closed, 35mm
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
FDA 510(k)
FDA Class 2
·Orthopedic
JULIET LL
FDA 510(k)
FDA Class 2
·Orthopedic
BD SAFETY-LOK
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·November 26, 2023
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 17, 2011
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 10, 2014
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·July 22, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014