15 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
FDA 510(k)
FDA Class 2
·General Hospital
LC-DCP
FDA UDI
Synthes GmbH·10886982168283·2.7MM LC-DCP® PLATE 8 HOLES/77MM
ARKEO, Wedge Fixation System
FDA UDI
Auxano Medical LLC·00850055649958·ARKEO Evan's Wedge Trial, 22x22x08
OsteoMed
FDA UDI
OSTEOMED LLC·00845694023078·FPS 3.5/4.0mm 8 Hole Straight Plate
Portex
FDA UDI
ICU MEDICAL, INC.·15019517077599·
OsteoMed
FDA UDI
OSTEOMED LLC·00845694077729·FPS 3.5/4.0 8 Hole Straight Plate Sterile Qty 2
ISIS MER SYSTEM/ELEKTA MER SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
Monopolar Laparascopic Accessories
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 2, 2025
BD NEXIVA
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·May 13, 2025
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code LWR·November 18, 2008
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·September 9, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
FDA Recall
Terminated
·Cardima Inc·Product code OCL·May 20, 2010
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA
FDA Recall
Terminated
·Cardima Inc·Product code OCL·May 20, 2010