10 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERF-LOCK IMPRESSION TRAY
FDA 510(k)
FDA Class 1
·Dental
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209128884·
ANTERIOR BUTTRESS PLATE
FDA 510(k)
FDA Class 2
·Orthopedic
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
FDA 510(k)
FDA Class 2
·Orthopedic
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·October 16, 2007
ASR UNI FEMORAL IMPL SIZE 41
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 23, 2012
UNK - CONSTRUCTS: LCP COMPACT FOOT/COMPACT HAND PLATE AND SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·January 7, 2025
UNK - CONSTRUCTS: TITANIUM MESH PLATE AND SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·January 8, 2025
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc.·April 7, 2021