116 results
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28ms
·
Sources: EU EUDAMED, US FDA
Somatic Gene Mutation Detection System
FDA Pre-Market Approval
FDA Class 3
·CRCDx RAS Mutation Detection Assay Kit
ACRY PRINT RU-005 Guide
FDA UDI
pro3dure medical GmbH·EPRC0220005·ACRY PRINT RU-005 Guide
1000g
Clear-Transparent
PMT® Halo Systems
FDA UDI
PMT CORPORATION·00650551122715·HALO, 1220-5 VEST SMALL, LAMBSWOOL LINER, 1211-...
Zavation
FDA UDI
Zavation LLC·00842166132658·Ti3Z CIF 14mmx16mmx5mm -0 deg
OsteoMed
FDA UDI
OSTEOMED LLC·00845694007399·1.1mm Pilot Drill, 4mm Stop, Manual
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR75912200051·Buccal tube Single .022" f. weld. max. 6 left
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR74902200051·Buccal tube Edgew./Ricketts .022" f. weld. max....
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR75612200051·Buccal tube Single .022" f. weld. mand. 6 left
TENS & PMS Unit
FDA 510(k)
FDA Class 2
·Neurology
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Automated External Defibrillators (Non-Wearable)
FDA Pre-Market Approval
FDA Class 3
·TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors
XACT CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR DEVICES IRELAND, LTD.·Product code NIM·April 5, 2006
LIGAMAX-5MM
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·August 23, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·June 30, 2008
RIATA ACTIVE FIXATION
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·G5 Mobile Continuous Glucose Monitoring System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Dexcom G5 Mobile Continuous Glucose Monitoring System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·Dexcom G4 Platinum/G5 Mobile Continuous Glucose Monitoring System
Sensor, Glucose, Invasive
FDA Pre-Market Approval
FDA Class 3
·DEXCOM G4TM PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM