21 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
FDA 510(k)
FDA Class 2
·Orthopedic
COLLATEK POWDER
FDA 510(k)
FDA Unclassified
·Unknown
BRAINLAB KNEE
FDA 510(k)
FDA Class 2
·Neurology
MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION SAS·Product code FTL·September 11, 2019
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·February 20, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code KNQ·September 7, 2012
AUTOPULSE RESUSCITATION SYSTEM MODEL 100
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·June 3, 2013
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 18, 2013
AUTOPULSE LI-ION BATTERY
FDA Adverse Event
Malfunction
·ZOLL CIRCULATION, INC.·Product code DRM·May 23, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·January 7, 2013
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEATHCARE·Product code KDJ·May 15, 2013
OCTRODE
FDA Adverse Event
Injury
·ST JUDE MED - NEUROMODULATION·Product code GZB·September 17, 2014
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·March 13, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·August 10, 2012
CRE? WIREGUIDED
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code KNQ·June 6, 2013
CRE¿ WIREGUIDED
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KNQ·December 5, 2012
CRE¿ WIREGUIDED
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - CORK·Product code KNQ·July 2, 2012
Vanguard XP Tibial Tray 69 mm Item # 195248
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 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