9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CorticaLINK Spinal Fusion Platform
FDA 510(k)
FDA Class 2
·Orthopedic
AGXO
FDA UDI
Oticon A/S·05707131343000·G200, MINIRITE 312 2.4G C093 AGXO
FUSION SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNAPSE 3D CARDIAC TOOLS
FDA 510(k)
FDA Class 2
·Radiology
PLUM A+3 PUMP MEDNET WIRELESS
FDA Adverse Event
Malfunction
·HOSPIRA, INC.·Product code FRN·October 7, 2008
ROLLER BENDER FOR RECON MANDIBULAR PLATES
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·July 13, 2011
UNKNOWN DEPUY ALL-POLY UNI TIBIA
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·June 27, 2013
PEDICLE SCREW 03.50.054 PEDICLE SCREW 8X40MM
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 16, 2023
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024