12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Sorrento Bone Graft Substitute
FDA 510(k)
FDA Class 2
·Orthopedic
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code KWP·June 10, 2020
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·January 5, 2018
MITEK VAPR COOLPULSE 90 ELECTRODE
FDA Adverse Event
Malfunction
·DEPUY MITEK·Product code GEI·October 21, 2014
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 26, 2013
EON MINI IPG, 16-CHANNEL RECHARGEABLE
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 25, 2011
UNKNOWN HIP FEMORAL AUGMENT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 16, 2020
UNKNOWN HIP FEMORAL HEAD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·April 16, 2020
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·February 4, 2015