21 results · 22ms · Sources: EU EUDAMED, US FDA

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ENTire IRE System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

DIOMED DELTA 15, MODEL DELTA 15; DIOMED DELTA 30, MODEL DELTA 30

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

TAURUS C1

FDA 510(k)
FDA Class 1 ·Dental

ALLERGAN

FDA Adverse Event
Other ·ALLERGAN MEDICAL OPTICS·Product code HQL·August 13, 1998

SMOOTH BECKER EXPANDER/MAMMARY PROSTHESIS

FDA Adverse Event
Injury ·MENTOR·Product code FTR·November 24, 1998

NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR CHILDREN

FDA Adverse Event
Injury ·COCHLEAR LTD·Product code MCM·December 17, 1996

M/H MODULAR CALCAR STEM

FDA Adverse Event
Injury ·BIOMET, INC.·Product code JDI·June 19, 1998

CRYOVALVE

FDA Adverse Event
Injury ·CRYOLIFE, INC.·Product code MIE·June 8, 1998

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·September 9, 2025

SYNTHES

FDA Adverse Event
Injury ·SYNTHES·Product code KWQ·July 9, 1998

14MM UNIVERSAL FEMORAL

FDA Adverse Event
Injury ·SYNTHES (USA)·Product code JDS·February 15, 2002

AUTO SUTURE SURGINEEDLE 150MM

FDA Adverse Event
Injury ·UNITED STATES SURGICAL CORP.·Product code GCJ·February 3, 1999

STAR

FDA Adverse Event
Injury ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LZS·May 14, 2019

ROTALINK CATHETER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC·Product code MCX·December 4, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 29, 2013

CUSTOM DISTAL FEMORAL REPLACEMENT IMPLANT

FDA Adverse Event
Malfunction ·STANMORE IMPLANTS WORLDWIDE LTD·Product code KRO·August 3, 2016

ELECTRIC DERMATOME HANDPIECE

FDA Adverse Event
Injury ·ZIMMERBIOMET SURGICAL·Product code GFD·September 22, 2015

PATHNET BLOOD BANK DONOR

FDA Adverse Event
Malfunction ·CERNER CORP.·Product code MMH·April 24, 1997

STAR S4 IR

FDA Adverse Event
Injury ·AMO MANUFACTURING USA, LLC·Product code LZS·February 11, 2021