16 results · 34ms · Sources: EU EUDAMED, US FDA

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ICON (TM) MODULAR PEDICLE SCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

Surgical Instrument

FDA UDI
Jeil Medical Corporation·08800089448814·

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213032767·Coupling Treatment Tube for Metal Needles (8)

OPUS SPEEDSCREW SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

SYNTHES SCOUT TACK FIXATION

FDA 510(k)
FDA Class 2 ·Cardiovascular

VERSYS FEMORAL STEM

FDA Adverse Event
Injury ·ZIMMER INC·Product code LPH·February 25, 2016

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·May 14, 2013

VERSACARE

FDA Adverse Event
Malfunction ·HILL-ROM RITTER·Product code FNL·August 14, 2008

ASR ACETABULAR CUPS 58

FDA Adverse Event
Injury ·DEPUY INTL, LTD.·Product code KWA·May 13, 2011

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

UNKNOWN VLOC PRODUCT

FDA Adverse Event
Injury ·COVIDIEN, FORMERLY US SURGICAL A DIVISON·Product code GAM·September 29, 2015

ACHIEVE MAPPING CATHETER

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code DRF·November 14, 2019

FLEXCATH ADVANCE STEERABLE SHEATH

FDA Adverse Event
Injury ·MEDTRONIC CRYOCATH LP·Product code DRA·November 14, 2019

INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

Model Number L131, ESSENTIO DR EL MRI Pacemaker

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025