48 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TAMPAX PEARL SCENTED AND UNSCENTED TAMPONS - JUNIOR, REGULAR, SUPER & SUPER PLUS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DEPUY GLOBAL UNITE SHOULDER SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ZYPLAST COLLAGEN IMPLANT
FDA Adverse Event
Injury
·COLLAGEN CORP.·Product code LMH·May 14, 1997
SMOOTH SALINE MAMMARY PROSTHESES
FDA Adverse Event
Injury
·MENTOR·Product code FWM·August 10, 1998
SURESTEP
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code CGA·October 13, 1998
OMNIFIT 0 DEGREE CUP INSERT
FDA Adverse Event
Injury
·HOWMEDICA INC.·Product code LWJ·December 21, 1999
DURALOC 28MM ID NEUT HYLAMER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWB·October 6, 1997
OMNIFIT PSL MICROSTRUCTURED
FDA Adverse Event
Injury
·HOWMEDICA INC.·Product code KWB·December 21, 1999
TSRH RODS, PLATES, SCREWS
FDA Adverse Event
Injury
·SOFAMOR DANEK GROUP INC.·Product code KWP·September 3, 1997
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·May 28, 2026
COATED VICRYL (POLYGLACTIN 910) SUTURE
FDA Adverse Event
Injury
·ETHICON, INC. SAN ANGELO·Product code GAM·February 22, 2001
TRUWAVE
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026
VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS·Product code LWS·March 6, 1997
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·January 11, 2013
DT-6012R
FDA Adverse Event
Malfunction
·OHMEDA (S) PTE. LTD.·Product code DXN·December 7, 1996
NICOLET
FDA Adverse Event
Injury
·NATUS NEUROLOGY INCORPORATED·Product code GWJ·November 7, 2013
SYNTHESIS
FDA Adverse Event
Injury
·SYNTHES·Product code HRS·September 23, 1997
SILASTICAL (R) MAMMARY PROSTHESIS
FDA Adverse Event
Injury
·DOW CORNING CORP·Product code FTR·October 11, 1996
SYNTHES
FDA Adverse Event
Injury
·SYNTHES·Product code KWQ·January 8, 1998