11 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TRAUMAGEL®
FDA 510(k)
FDA Unclassified
·Unknown
OTICON, INC.
FDA registration
OTICON, INC.·4 products·🇺🇸 United States
Plateau-X Spacer System
FDA UDI
Life Spine, Inc.·00190837012526·
MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PLANMECA ROMEXIS
FDA 510(k)
FDA Class 2
·Radiology
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code FNJ·November 10, 2014
ALTRX +4 NEUT 40IDX56OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·September 9, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FKX·July 22, 2013
BIOMET StageOne Knee Femoral Cement Spacer Mold, 60 MM, Silicone, Sterile, Item 432160.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BIOMET StageOne Knee Tibial Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 433165.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
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