14 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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WHITESIDE ORTHOLOC M.A. TIBIAL BASE
FDA 510(k)
FDA Class 2
·Orthopedic
Snowden-Pencer
FDA UDI
STERIS CORPORATION·10885403181795·DIAMOND-FLEX 40 DEG ARTICULATING FORCEPS BABCOC...
SARTORIUS MINISART SM 16596HY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESKA JONAS SILICON-SILVER PENILE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 23, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 23, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 23, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 23, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 23, 2024
AIR DERMATOME HANDPIECE
FDA Adverse Event
Malfunction
·ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS·Product code GFD·April 25, 2014
ACUITY
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·November 9, 2010
XIA PRECISION K-WIRE SHARP
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code NKB·December 27, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020
ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026