116 results · 28ms · Sources: EU EUDAMED, US FDA

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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