11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CONSENSUS ZIRCONIA FEMORAL HEAD
FDA 510(k)
FDA Class 2
·Orthopedic
DISTAT ANTI-DSDNA KIT
FDA 510(k)
FDA Class 2
·Immunology
ADHESIVE E.T. TAPE
FDA 510(k)
FDA Class 1
·Anesthesiology
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
FDA Adverse Event
Malfunction
·MEDTRONIC MILACA INC·Product code LWP·February 11, 2013
ACCU-CHEK ® COMPACT TEST DRUM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·January 10, 2011
5.0 CM SHORT ATTACHMENT
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HBC·December 13, 2013
SCREW,FIXATION,BONE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·December 17, 2018
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
STAGBEETLE FORCEPS 125MM
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·May 25, 2017
STAGBEETLE FORCEPS 125MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code LXH·August 16, 2019
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.
FDA Enforcement
Class I
·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021