14 results · 21ms · Sources: EU EUDAMED, US FDA

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PONTO BONE ANCHORED HEARING SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

CoRoent

FDA UDI
Nuvasive, Inc.·00887517289216·CoRoent® Large MP, 12x9x28 12°

Integra® Jarit®

FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780377559·Integra® Jarit® Castroviejo Needle Holder, 7-1/...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587T1212280·12mm TLIF Implant 12mm Wide 28mm Length

TASMIN R 12°

FDA UDI
SIGNUS Medizintechnik GmbH·04047844014882·The basic shape of the TASMIN R devices is a ho...

Yellowstone

FDA UDI
SUMMIT SPINE LLC·B587T12122870·12mm TLIF Implant 12mm Wide 28mm Length 7 Degrees

T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code OZO·April 21, 2020

MIRADA XD

FDA 510(k)
FDA Class 2 ·Radiology

HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE

FDA 510(k)
FDA Class 2 ·Cardiovascular

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·May 16, 2025

POWERED WHEELCHAIR

FDA Adverse Event
Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 20, 2013

SPRINT QUATTRO SECURE

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011

IN TOUCH ZX

FDA Adverse Event
Malfunction ·STRYKER MEDICAL QUEBEC, LP·Product code FNL·August 16, 2008

Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

FDA Enforcement
Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012