285 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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OLYMPUS Pediatric Knives and Resection Electrodes The pediatric knives are intended for use in urethrotomy in pediatric applications. The HF resection electrodes are intended for use in transurethral resection in pediatric applications.
FDA Recall
Terminated
·Olympus America Inc.·Product code EZO·December 22, 2010
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
FDA Recall
Terminated
·Biosense Webster, Inc.·Product code DQK·March 5, 2013
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·April 3, 2013
DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
EDI BZO Uncut Sheet - Cup*, Item No. 160170
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
BZO Strip Dip Card (300ng/ml)*, Item No. 100170
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
PENTARAY NAV High-Density Mapping Catheter.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·December 13, 2017
ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse Test (MET1000/OPI2000)+AMP+BZO+COC+THC", PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test (COC/THC)+BZO+MTD+OPI300+OXY", PSCUP-5M-W/ ProScreen" Drugs of Abuse Cup AMP/COC/MET1000/OPI2000/THC), PSD-10MOB "ProScreen" Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA)+AMP+BZO+BUP+MTD", PSD-5M / "ProScreen" Drugs of Abuse Test AMP/COC/MET1000/OPI2000/THC", PSCUPA-10OM / ProScreen" Drugs of Abuse Cup (COC/THC)+(MET1000/OPI2000)+(OXY/ MDMA) +(PCP/AMP)+BAR+BZO
FDA Recall
Terminated
·Ameditech Inc·Product code DKC·August 18, 2020
ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
11 Panel Card (OPI 300) w/Adult, Item No. 71125AA
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
1 Step 12 Panel Cup, Item No. NBCA-12M-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 12 Panel Dip Card, Item No. PSD-12BUP
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015
ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300
FDA Recall
Terminated
·Ameditech Inc·Product code JXM·November 16, 2015