19 results · 19ms · Sources: EU EUDAMED, US FDA

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SMITH & NEPHEW RJ CONSTRAINED LINERS

FDA 510(k)
FDA Class 2 ·Orthopedic

MicroSelectron Digital

FDA UDI
Nucletron B.V.·08717213026384·microSelectron Transfer Tube for 6F Flexibles (25)

DONJOY

FDA UDI
DJO, LLC·00888912018081·ICEMAN CLEARCUBE W/SHOULDER, S WRAP-ON PAD, NS, RH

DONJOY

FDA UDI
DJO, LLC·00190446738374·ICEMAN CLEAR3 W/ SHLDR, S WRAP-ON PAD, NS, RH, ...

AIRCAST

FDA UDI
DJO, LLC·00190446136620·ICEMAN CLEARCUBE W/SHOULDER, S WRAP-ON PAD, NS,...

DREAMSTATION AUTO CPAP

FDA Adverse Event
Injury ·RESPIRONICS, INC.·Product code BZD·September 30, 2022

TD-4239 BLOOD GLUCOSE MONITORING SYSTEM AND TD-4239 MULTI BLOOD GLUCOSE MONITORING SYSTEM

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

INOMAX DS(IR) (DELIVERY SYSTEM)

FDA 510(k)
FDA Class 2 ·Anesthesiology

DRIVER; SIZE 10

FDA Adverse Event
Malfunction ·K2M, INC.·Product code LXH·July 12, 2022

¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code FTL·September 23, 2015

PLUM A + DRIVER NEW

FDA Adverse Event
Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·May 7, 2013

MINICAP

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 2, 2011

TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·August 13, 2008

ZENAPRO HYBRID HERNIA REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH, INC.·Product code FTL·August 8, 2014

¿ZENAPRO HYBRID HERNIA REPAIR GRAFT

FDA Adverse Event
Injury ·COOK BIOTECH·Product code FTL·November 30, 2015

OSCOR ADELANTE BREEZEWAY 8F C90¿ S79CM D84CM Catalog # AB081046 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.

FDA Enforcement
Class II ·Terminated·Oscor, Inc.·December 28, 2016

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

EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

FDA Enforcement
Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

Model Number L231, PROPONENT DR EL MRI Pacemaker

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