14 results
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18ms
·
Sources: EU EUDAMED, US FDA
FOAMIES DIAPOS. FOAM RUBBER PADS
FDA 510(k)
FDA Class 2
·Neurology
NA
FDA UDI
LANCER ORTHODONTICS, INC.·00817573024117·MODULES-SAFETY 450g BLUE 10/PK
Life Instruments
FDA UDI
Life Instrument Corporation·M93078306010T0·Titanium Metzenbaum Scissor Cvd 150mm
Life Instruments
FDA UDI
Life Instrument Corporation·M93078306011T0·Titanium Metzenbaum Scissor Cvd 150mm
VERTE-STACK SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BIOROOT RCS
FDA 510(k)
FDA Class 2
·Dental
PYRAMESH® IMPLANT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code EZX·July 17, 2014
BOOMERANG PEEK FUSION DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·January 14, 2011
CORE IMPACTION DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code DZJ·May 23, 2014
COAGUCHEK® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·November 13, 2012
DURATA STS OPTIM ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 10, 2010
PYRAMESH IMPLANT SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDICS·Product code EZX·December 9, 2016
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018