1,025 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
FDA Enforcement
Class III
·Terminated·CooperSurgical, Inc.·October 14, 2015
Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
DrugSmart 9 Test Cup (BUP), Item No. 60960D
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per container, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae.
FDA Enforcement
Class III
·Terminated·Biomerieux Inc·April 15, 2015
ProScreen 5 Panel Dip Card, Item No. PSD-12BUP
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015