18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ELITECH CLINICAL SYSTEMS BILIRUBIN TOTAL 4+1, ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTMES ELITROL I & II
FDA 510(k)
FDA Class 2
·Clinical Chemistry
JOBST Men's Dress
FDA UDI
BSN MEDICAL, INC.·00035664107802·MEN'S DRESS 8-15 MM HG KNEE HIGH CLOSED TOE SMA...
NA
FDA UDI
MAKO SURGICAL CORP.·00848486017217·ANTERIOR LATERAL BROACH ARRAY
LuxaPost
FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG1107801·Core-build-up and post cementation. Content: 5 ...
Marina Medical
FDA UDI
MARINA MEDICAL INSTRUMENTS, INC.·00840306818288·Atlas™ Rigid Arm- Single Long Straight Column w/
VITAL SUTURES, SUTUREX, CIRUGIA PERUANA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TROCHANTERIC NAIL
FDA 510(k)
FDA Class 2
·Orthopedic
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code JAA·April 3, 2013
GALAXY INTRAVASCULAR ULTRASOUND SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - FREMONT (SUD)·Product code IYO·May 14, 2013
RESERVOIR 1.8ML
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code FRN·September 23, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 1, 2011
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·July 8, 2019
TOSHIBA Kalare Diagnostic X-Ray System K110785
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·July 17, 2013
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 6, 2019
EQUINOXE
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWT·March 26, 2021
UNKNOWN SCREW
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·March 20, 2015
Video Duodenoscope
FDA Enforcement
Class II
·Terminated·Pentax Medical Company·June 8, 2016
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012