15 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Pastelle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776407803·Hibbs Osteotome, 9 1/2", curved, 7/8"
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780188230·Integra® Jarit® Hibbs Osteotome, 9-1/2", Curved...
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690117537·Distal Reamer (Hudson)
Adler Instrument Company
FDA UDI
Adler, Inc.·00810123204120·LAHEY TRACT FCPS 8
Stainless Steel Archwire
FDA UDI
Ortho Arch Company Inc·D90925016516·.020 X .020 UPPER SS RIGHT FORM ARCHWIRES (10)
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690192602·Distal Reamer (Hudson)
GC85A
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 24, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 8, 2025
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 15, 2011
THUNDERBEAT 5MM, 20CM INLINE GRIP
FDA Adverse Event
Malfunction
·OLYMPUS MEDICAL SYSTEMS CORPORATION·Product code GEI·November 5, 2014
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013