14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AB DENTAL DEVICES IMPLANTS AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Dental
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741124400·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674112440060·
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169605237·SPACER 2112440 OLIF25 20MM 12 DEG 14X40
2880 CLRA
FDA UDI
HANS RUDOLPH, INC.·00874750008827·CLRA 8200/2600
Experience
FDA UDI
Gc Orthodontics America Inc.·E535112440Z0101·EXZ ROTH 022/LR4 -17T 0A 4D
Experience
FDA UDI
Gc Orthodontics America Inc.·D788112440Z0101·EXZ ROTH 022/LR4 -17T 0A 4D
QUICK UP
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO CLEARFIL LINER BOND 2V
FDA 510(k)
FDA Class 2
·Dental
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523100811·L CR Cemented Femoral Component Sz 4N
SUMMIT POR TAPER SZ4 STD OFF
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code LPH·May 14, 2013
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 24, 2014
4 MOTOR ADVANCE BED
FDA Adverse Event
Malfunction
·HILL-ROM INC.·Product code FNL·April 28, 2011
Model Number L131, ESSENTIO DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025