24 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Preci-Vertix
FDA UDI
Preat Corporation·00842092108994·Preci-Vertix Laser Males TI
Endo Carry-On Procedure Kit
FDA UDI
MEDIVATORS INC.·00677964069437·Endo Carry-On Procedure Kit
SEMIAL 10°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844000915·The KIMBA®, KIMBA® mini, MOBIS® and NOVAL™ impl...
NITANIUM ARCHWIRE
FDA UDI
Ortho Organizers, Inc.·00190707057589·.019 x .025 NITANIUM 20° TORQUED ARCHWIRE 38mm...
Vascular Silicones Ties, Extra Maxi White, sterile
FDA UDI
Batrik Medical Manufacturing Inc·00690521022294·Vascular Silicone Ties, Radio Opaque, Sterile, ...
S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GENZYME DIRECT-AMYLASE TEST REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Widex
FDA UDI
Widex A/S·05706069722055·Widex D-FS BTE (Shocking pink S-220 ) Telecoil,...
Widex
FDA UDI
Widex A/S·05706069721737·Widex UNIQUE U-FS BTE (Shocking pink S-220 ) Te...
Widex
FDA UDI
Widex A/S·05706069773316·Widex EVOKE E-PA (Shocking pink S-220 ) RC coil
UNKNOWN DEPUY LPS 18.5X200 PF STEM
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 9, 2013
THE BELMONT RAPID INFUSER
FDA Adverse Event
Other
·BELMONT INSTRUMENT CORP.·Product code FRN·May 18, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·August 7, 2008
Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016
Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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