14 results · 21ms · Sources: EU EUDAMED, 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