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