15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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QA-40M DEFIBRILLATOR TESTER
FDA 510(k)
FDA Class 2
·Cardiovascular
SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
FDA 510(k)
FDA Unclassified
·Unknown
InMode RF System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HWC·June 7, 2018
HUDSON THERMAGARD NEBULIZER HEATER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BTT·May 20, 2014
APOGEE SYSTEM
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·February 12, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·January 18, 2011
8.0MM/4.2MM DRILL SLEEVE 200MM
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code FSM·May 22, 2015
RECON LOCKING AIMING ARM FOR LATERAL ENTRY FEMORAL NAILS-EX
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code FZX·May 22, 2015
4.2MM TROCAR 210MM
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code FSM·May 22, 2015
12.0MM/8.0MM PROTECTION SLEEVE 188MM
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code FSM·May 22, 2015
PERCUTANEOUS INSERTION HANDLE
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code LXH·May 22, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HWC·March 8, 2016
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HWC·March 11, 2016
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·March 25, 2015