14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WANDY DISPERSVIE ELECTRODE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NOVO Health Services, LLC
FDA UDI
NOVO HEALTH SERVICES, LLC·00812564032065·Labor & Delivery Pack
ArgenZ Anterior 95x16 #2
FDA UDI
ARGEN CORPORATION, THE·D818121268·Dental porcelain/ceramic restoration kit
ECLIPSE, HELIOS OPTION
FDA 510(k)
FDA Class 2
·Radiology
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·March 26, 2013
CONTOUR USB
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE LLC·Product code NBW·December 14, 2012
CONTOUR NEXT
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·July 27, 2012
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
WAVEWRITER ALPHA? 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 2, 2025
PULSE GEN MODEL UNK
FDA Adverse Event
Injury
·CYBERONICS·Product code LYJ·May 20, 2013
ASR ACETABULAR CUPS 48
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·June 1, 2011
WHEELCHAIR, BARIATRIC, 28", REM D
FDA Adverse Event
Other
·MEDLINE INDUSTRIES, INC.·Product code IOR·August 15, 2008
cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Corporation·March 14, 2018