13 results
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19ms
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Sources: EU EUDAMED, US FDA
ORTHODAPTIC* BONDING ADHESIVE
FDA 510(k)
FDA Class 2
·Dental
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780535089·Programmable Valve Cylindrical valve with Uniti...
CODMAN® HAKIM®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780519850·CODMAN® HAKIM® Programmable Valve with Unitized...
CODMAN HAKIM RICKHAM
FDA UDI
Cerenovus, Inc.·10886704041870·CODMAN HAKIM Programmable Valve with Unitized R...
GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PRECIMED HIP SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VALVE
FDA Adverse Event
Injury
·CODMAN & SHURTLEFF, INC·Product code JXG·August 18, 2014
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·November 30, 2007
SERVO-I
FDA Adverse Event
Malfunction
·MAQUET CRITICAL CARE AB·Product code CBK·February 21, 2014
DEROYAL
FDA Adverse Event
Malfunction
·DEROYAL INTERCONTINENTAL, S.A.R.·Product code HIF·October 10, 2012
CHPV CYL W/RR UN120CM DIST
FDA Adverse Event
Injury
·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·January 5, 2021
CHPV CYL W/RR UN120CM DIST
FDA Adverse Event
Malfunction
·CODMAN & SHURTLEFF, INC.·Product code JXG·April 27, 2016
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012