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

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2MP Color LCD Monitor, RadiForce RX250 and RX250-AR

FDA 510(k)
FDA Class 2 ·Radiology

N/A

FDA UDI
GEORGE TIEMANN & CO.·B5821602470·SCISSORS, SURGICAL TISSUE, DENTAL

Monza Cervical Plate System

FDA UDI
Altus Spine, LLC·B41711602471·47mm Cervical Plate, 2 Level

Denovo general purpose dental molar band

FDA UDI
Denovo Dental, Inc.·00810059290402·Denovo general purpose dental molar band - Mand...

MEDEX 3-WAY STOPCOCK

FDA Adverse Event
Malfunction ·ICU MEDICAL, INC.·Product code FMG·April 20, 2026

DETAX IMPLANTLINK SEMI

FDA 510(k)
FDA Class 2 ·Dental

LIFE SPINE CEMENT RESTRICTOR

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

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·July 26, 2021

ACCU-CHEK ® SPIRIT

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code LZG·February 12, 2014

Panda Infant Radiant Warmer Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment.

FDA Enforcement
Class I ·Terminated·GE Healthcare, LLC·July 17, 2019

ANIMAS VIBE

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·October 3, 2014

HOMECHOICE PRO

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·July 13, 2011

COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 16, 2008