11 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
FDA 510(k)
FDA Class 2
·Immunology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123076·K-WIRE - DOUBLE TROCAR 1.1mm DIA x 75mm
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
FDA 510(k)
FDA Class 2
·Orthopedic
AEYE-DS
FDA 510(k)
FDA Class 2
·Ophthalmic
E1 RINGLOC BIPOLAR 28X51MM
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code LZO·June 17, 2019
AEYE-DS RETINA SCREENING
FDA Adverse Event
Injury
·AEYE HEALTH INC.·Product code PIB·January 22, 2025
BIOMEX SHELL PC DIA48MM LN 22
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·December 2, 2015
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code BTI·January 17, 2013
ELECTROSURGERY PROBE PLUS II
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·December 13, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·July 9, 2014
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code MDB·January 28, 2022