23 results · 22ms · Sources: EU EUDAMED, 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