11 results
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26ms
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Sources: EU EUDAMED, US FDA
RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Syntec Internal Hex Captured Screw
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782906987·Syntec Internal Hex Captured Screw φ5.0 x L95mm
Syntec Femoral Nail System
FDA UDI
SYNTEC SCIENTIFIC CORPORATION·04712782906710·Syntec Internal Hex Captured Screw φ5.0 x L95mm
Diazyme Lipoprotein (a) Assay
FDA 510(k)
FDA Class 2
·Immunology
ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
FDA 510(k)
FDA Class 2
·Dental
REVISION MODULAR NECK H.70MM
FDA Adverse Event
Injury
·LIMACORPORATE SPA·Product code LZO·April 5, 2019
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·May 6, 2014
UNIVERSAL DRIVER SHAFT
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·October 5, 2010
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·December 19, 2012
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·October 25, 2017