8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036
FDA 510(k)
FDA Class 2
·Radiology
SYNSPAR ADVANCED
FDA 510(k)
FDA Class 2
·Dental
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·October 25, 2018
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 22, 2013
UNK DEPUY SZ3 8MM INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·December 9, 2010
RESOLUTION CLIP CLIPPING DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code KOG·July 9, 2014
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022