13 results · 22ms · Sources: EU EUDAMED, US FDA

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NeuroBlate System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MONTERIS MEDICAL NEUROBLATE SYSTEM

FDA Adverse Event
Malfunction ·MONTERIS MEDICAL CORPORATION·Product code GEX·April 22, 2015

HUMERAL NAIL

FDA UDI
Biomet Orthopedics, LLC·00887868004858·

IOS EXTERNAL FIXATOR, MODEL 2-0-0

FDA 510(k)
FDA Class 2 ·Orthopedic

OSSEOTITE II MODEL XIFOSSXXX

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 17, 2024

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 2, 2025

CUSA EXCEL 23KHZ TUBING SET

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES(IRELAND)·Product code LFL·October 5, 2018

ECHELON*FLEX45

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 14, 2013

BIRD

FDA Adverse Event
Malfunction ·CAREFUSION·Product code BZR·June 22, 2011

CYPHER SIROLIMUS-ELUTING CORONARY STENT

FDA Adverse Event
Malfunction ·CORDIS DE MEXICO·Product code NIQ·September 15, 2008

F-T3SYSTEM, T3 (Trumpf Table Top) System The device is a surgical table accessory system used to allow prone positioning on OR table tops during spinal surgery. The system consists of a table top frame, arm supports,

FDA Enforcement
Class II ·Terminated·Allen Medical Systems·April 4, 2018

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

FDA Enforcement
Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022