10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
FDA 510(k)
FDA Class 2
·Orthopedic
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481476644·
ENSIL FABRIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MANUAL DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-502
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·February 12, 2026
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
FDA Adverse Event
Injury
·SYNTHES USA·Product code NKB·December 29, 2015
PENUMBRA 6F NEURON DELIVERY CATHETER 070
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code DQY·May 2, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·September 15, 2014
SD/PD LONG CURVED
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS KALAMAZOO·Product code HBE·April 19, 2011
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