13 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio
FDA 510(k)
FDA Class 2
·Radiology
Cell-Chex
FDA UDI
STRECK, INC.·00844509000280·Cell-Chex is a body fluid procedural control fo...
D-LISH
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·00302730002171·Young D-Lish 5% Sodium Fluoride Varnish, 0.40mL...
D-Lish Fresh Melon Varnish 200
FDA UDI
YOUNG DENTAL MANUFACTURING I, LLC·10302732124205·
ONCENTRA PROSTATE 4.0
FDA 510(k)
FDA Class 2
·Radiology
DIAZYME 25-HYDROXY VITAMIN D EIA KIT DIAZYME 25-HYDROXY VITAMIN D EIA CONTROL SET DIA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Injury
·TANDEM DIABETES CARE·Product code QFG·July 22, 2022
NATRELLE INSPIRA FULLPROF 485CC SIZER US
FDA Adverse Event
Malfunction
·ALLERGAN (COSTA RICA)·Product code MRD·June 20, 2025
VENTED AUTOFEED HUMIDIFICATION CHAMBER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·August 16, 2011
MECHANICAL WALKER, ROLLATOR
FDA Adverse Event
GENTEEL HOMECARE PRODUCTS·Product code ITJ·October 30, 2014
INGENIO
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 9, 2013
Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. For the rapid, qualitative detection of human hemoglobin in feces.
FDA Enforcement
Class II
·Terminated·Polymedco, Inc·April 10, 2013
DRX Revolution Mobile X-Ray System
FDA Enforcement
Class II
·Ongoing·Carestream Health, Inc.·December 13, 2023