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