8 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PASS LP Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
ONE TOUCH ULTRA
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code CFR·October 8, 2003
EVERON CENTRAL DISPLAY STATION - CDS, MODEL VERSION 1.0.0
FDA 510(k)
FDA Class 2
·Cardiovascular
SPINESMITH CYNCH SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SIG MOD TIB TRAY CEM COCR 5
FDA Adverse Event
Injury
·DEPUY CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·October 3, 2008
OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
FDA Adverse Event
Injury
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FJI·June 21, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·August 4, 2011
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024