13 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW
FDA 510(k)
FDA Class 2
·Orthopedic
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·October 30, 2017
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
FDA 510(k)
FDA Class 2
·Immunology
ACUMATCH GXL 15DEG LINER 36MM SZ J
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·April 19, 2024
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·January 21, 2010
VERTE-STACK SPINAL SYSTEM
FDA Adverse Event
Malfunction
·SOFAMOR DANEK DEGGENDORF GMBH·Product code ODP·November 20, 2009
EEA 28MM SINGLE-USE STAPLER
FDA Adverse Event
Injury
·COVIDEN, FORMERLY US·Product code GDW·March 14, 2013
OBTRYX SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·March 17, 2011
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·March 27, 2008
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
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