10 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MMG BILE BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327623673·2.9X12.5MM DRILL, HIP
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327623789·2.9X15.5MM DRILL
KNOTILUS+
FDA UDI
STRYKER CORPORATION·07613327623703·2.9X12.5MM DRILL
SIGN IM NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
Neocis Guidance System (NGS) with Intraoral Fiducial Array
FDA 510(k)
FDA Class 2
·Dental
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 30, 2010
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 11, 2013
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code NVY·July 2, 2014
1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025