14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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