9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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REST MATTRESS
FDA 510(k)
FDA Class 2
·General Hospital
N/A
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00613994122766·INSTRUMENT 6971568 TRL CUT GUID 8MMX16MM
SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
FDA 510(k)
FDA Class 2
·Orthopedic
IMPLANTABLE PULSE GENERATOR PACEMAKERS
FDA 510(k)
FDA Class 3
·Cardiovascular
ULTRAPRO HERNIA SYSTEM
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·February 21, 2013
HAKIM PROG VALVE INLINE SIPHONGUARD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC., MEDOS S.A.·Product code JXG·January 24, 2011
PROGRASP FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 31, 2014
REMINGTON MEDICAL DISPOSABLE PACING CABLE
FDA Adverse Event
Malfunction
·REMINGTON MEDICAL·Product code DSA·September 13, 2002
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021