21 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LCI OPTION FOR INNOCOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SPIRA-C
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPC1020470·Trial 12.5mm x 16mm Lordotic 7°, 11mm
SPIRA-L
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SPL1020470·Trial, Bi-Convex, 20° Lordotic, 22 x 60mm, 12mm
SPIRA®-A Integrated
FDA UDI
CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020470·SPIRA®-A Integrated,Trial, 26x34mm, 25° Lordoti...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523166008·MIS Acetabular Reamer, 47mm
RIVA STAR SILVER DIAMINE FLUORIDE
FDA Adverse Event
Injury
·SDI LIMITED·Product code LBH·February 13, 2019
3I CALCIUM SULFATE BONE CEMENT
FDA 510(k)
FDA Class 2
·Dental
DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
FDA 510(k)
FDA Class 2
·Cardiovascular
UniTip Catheter
FDA UDI
Unisensor AG·07640172971956·
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·April 22, 2013
HUDSON INCENTIVE SPIROMETER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BWF·April 13, 2011
UNIVERSAL DRIVER
FDA Adverse Event
Malfunction
·ABBOTT SPINE·Product code HXX·August 7, 2008
FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code HTO·December 17, 2014
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.
FDA Enforcement
Class II
·Ongoing·Medtronic Neurosurgery·July 26, 2023
Model Number L101, ESSENTIO DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Hemodialysis Delivery System, Software Version 2.x.
FDA Enforcement
Class II
·Ongoing·Baxter Healthcare Corporation·November 17, 2021