16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LATERAL SYNFIX
FDA 510(k)
FDA Class 2
·Orthopedic
DERMA+FLEX QS HIGH VISCOSITY TISSUE ADHESIVE MODEL: QS70404
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 18, 2016
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
COOK® CERVICAL RIPENING BALLOON
FDA Adverse Event
Malfunction
·COOK INC·Product code PFJ·July 19, 2016
DRILL SLEEVE LONG Ø3.2MM FOR BUTTRESS
FDA Adverse Event
Malfunction
·STRYKER GMBH·Product code LXH·October 1, 2014
SELF TAPING ORTHO SCREW
FDA Adverse Event
Injury
·SYNTHES·Product code HWC·May 9, 2013
ATTAIN ABILITY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code OJX·June 16, 2011
DIMENSION EXL 200
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC·Product code JJE·June 3, 2016
DIMENSION EXL WITH LM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJE·June 13, 2013
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 11, 2015
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
FDA Enforcement
Class I
·Terminated·Dexcom Inc·April 20, 2016