9 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.
FDA 510(k)
FDA Class 2
·Anesthesiology
Archon
FDA UDI
Nuvasive, Inc.·00887517309266·Archon Screw, 4.0x22mm S.D. Fixed
CARDIOSAVE Intra-Aortic Balloon Pump
FDA 510(k)
FDA Class 2
·Cardiovascular
FUSION MEDICAL CANNULATED SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·January 8, 2013
SMALL BATTERY DRIVE II
FDA Adverse Event
Malfunction
·SYNTHES OBERDORF·Product code HWE·June 18, 2014
GORE EXCLUDER AAA ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·October 20, 2010
LIFEVEST WCD 3100 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 16, 2012
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