23 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACIES
FDA 510(k)
FDA Class 2
·Radiology
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964069444·The ENDO CARRY-ON Procedure Kit contains all of...
Endeavour™ TruColor™ XL
FDA UDI
METREX RESEARCH, LLC·00810210820295·Endeavour™ TruColor™ XL headlight system - Nort...
NITANIUM ARCHWIRE
FDA UDI
Ortho Organizers, Inc.·00190707057572·.019 x .025 NITANIUM 20° TORQUED ARCHWIRE 34mm...
GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·September 30, 2020
Drill Stopper for Long L10 1842
FDA UDI
ADIN DENTAL IMPLANT SYSTEMS LTD·07290105157416·
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
FDA 510(k)
FDA Class 2
·Cardiovascular
SABRE COMPAC
FDA 510(k)
FDA Class 2
·Neurology
Drill Stopper for Long L15/Short L10 1842
FDA UDI
ADIN DENTAL IMPLANT SYSTEMS LTD·07290105157447·
Widex
FDA UDI
Widex A/S·05706069722048·Widex D-FS BTE (Shocking pink S-110 ) Telecoil,...
Widex
FDA UDI
Widex A/S·05706069773309·Widex EVOKE E-PA (Shocking pink S-110 ) RC coil
Widex
FDA UDI
Widex A/S·05706069721720·Widex UNIQUE U-FS BTE (Shocking pink S-110 ) Te...
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code MGB·June 23, 2023
FEMOSTOP GOLD
FDA Adverse Event
ST. JUDE MEDICAL·Product code DXC·May 7, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD·Product code JAA·May 10, 2011
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·August 6, 2008
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021