10 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Apollo TMS Therapy System;Apollo light TMS Therapy System
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101414·DIAMOND KNIFE 30 DEGREES
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
ASCENSION PYROSPHERE CMC/TMT
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·May 25, 2021
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 22, 2011
COULTER® LH 750 HEMATOLOGY ANALYZER.
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·August 1, 2013
BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 13 X 145 MM, 57 MM, Silicone, Sterile, Item 431213.
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 15, 2020
BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213
FDA Enforcement
Class II
·Terminated·Becton Dickinson & Co.·April 21, 2021