48 results · 24ms · Sources: EU EUDAMED, 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