15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PORTO-VAC
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
StimSox(TM) System
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCU-CHEK ® PERFORMA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·April 24, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 19, 2007
PFC SIG CRUC SUB SZ4 W/LUGS RT
FDA Adverse Event
Injury
·DEPUY RAYNHAM·Product code JWH·October 3, 2012
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code MAX·April 16, 2014
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code MAX·April 16, 2014
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code MAX·April 16, 2014
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code MAX·April 16, 2014
LEGION PS OXIN FEM SZ5 LT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·February 5, 2018
GII OVAL RESURFACING PAT 32MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·December 18, 2015
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code MAX·April 16, 2014
TAPERED U-JOINT DRIVER FOR SYNFIX MINI-OPEN
FDA Adverse Event
Malfunction
·SYNTHES BETTLACH·Product code MAX·April 16, 2014
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014