126 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION
FDA 510(k)
FDA Class 2
·Radiology
HairCheck-DT (Opiates)
FDA UDI
Quest Diagnostics·00868586000223·HairCheck-DT (Opiates) is an ELISA test kit use...
JOBST forMen
FDA UDI
BSN MEDICAL, INC.·04042809868753·FOR MEN 20-30 MM HG THIGH MICRO DOT BAND CLOSED...
LEKON
FDA UDI
C A I INDUSTRIES CORP·00807689004387·Acupuncture needles
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 3, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 3, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 10, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·September 11, 2019
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
FDA 510(k)
FDA Class 1
·Clinical Chemistry
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
FDA 510(k)
FDA Class 2
·Hematology
CD HORIZON® SPINAL SYSTEM
FDA Adverse Event
Death
·MEDTRONIC SOFAMOR DANEK·Product code KWP·May 4, 2017
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code KWP·July 8, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK USA, INC.·Product code KWP·October 30, 2019
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NKB·October 9, 2019
SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018
APPLIANCE, FIXATION, SPINAL INTERLAMINAL
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK·Product code KWP·October 4, 2017