14 results
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23ms
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Sources: EU EUDAMED, US FDA
CHESEBROUGH-POND'S MULTILAYER ELASTIC
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780535096·Programmable Valve Cylindrical valve with Uniti...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519867·CODMAN® HAKIM® Programmable Valve with Unitized...
CODMAN HAKIM RICKHAM
FDA UDI
Cerenovus, Inc.·10886704041887·CODMAN HAKIM Programmable Valve with Unitized L...
CHPV CYL W/LG RR NU120CM DIST
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES MANSFIELD·Product code JXG·February 27, 2024
STAIRFRIEND CURVED STAIRWAY CHAIRLIFT
FDA 510(k)
FDA Class 2
·Physical Medicine
VySpan PCT System
FDA 510(k)
FDA Class 2
·Orthopedic
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·February 21, 2014
MTOME ST HOLSTER/CABLES
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code KNW·November 30, 2007
IMPLANT PDS3000M 6PK PILLAR PALATAL
FDA Adverse Event
Injury
·XOMED MFG JACKSONVILLE·Product code LRK·October 29, 2012
CHPV CYL W/LG RR NU120CM DIST
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC. / MEDOS S.A.·Product code JXG·May 11, 2016
PROGRAMMABLE VALVE IN-LINE W/ SIPHONGUARD
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF·Product code JXG·October 7, 2014
CHPV CYL W/LG RR NU120CM DIST
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC.·Product code JXG·February 20, 2015
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012