90 results
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13ms
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Sources: EU EUDAMED, US FDA
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Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
FDA Recall
Terminated
·Stryker Howmedica Osteonics Corp.·Product code LXH·November 20, 2013
Therakos CellEx Photopheresis System; Photopheresis Procedural Kits, for use with the THERAKOS CellEx Instrument;
FDA Recall
Terminated
·Therakos Inc·Product code LNR·March 29, 2010
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
FDA Enforcement
Class II
·Terminated·Beckman Coulter Inc.·October 6, 2021
iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142; iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131; iCup DX 12 Panel w/Adulterant, Item No. I-DXA-1127-023; iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013; iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016; iCup DX Drug Screen, Item No. I-DXA-1127-023 These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿
FDA Enforcement
Class II
·Terminated·Ameditech Inc·November 25, 2015
iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD
FDA Recall
Terminated
·Ge Healthcare·Product code KGI·February 1, 2009
DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.
FDA Recall
Terminated
·Ge Healthcare·Product code KGI·February 1, 2009
DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.
FDA Recall
Terminated
·Ge Healthcare·Product code KGI·February 1, 2009
DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD.
FDA Recall
Terminated
·Ge Healthcare·Product code KGI·February 1, 2009
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
FDA Enforcement
Class II
·Terminated·Beckman Coulter Biomedical GmbH·September 30, 2020
Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD
FDA Recall
Terminated
·Ge Healthcare·Product code KGI·February 1, 2009
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
FDA Recall
Terminated
·Biomet, Inc.·Product code LXH·September 10, 2010
Alere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC Bl, Cr, Ni, pH, SG", I-DXA-13B/"Alere" iCup¿ DX Drug Screen Cup 13 Drug Detection + Adulteration AMP/BAR/BZO/BUPG/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC/TCA Bl, Cr, Ni, pH, SG", I-DXA-1127-023-N "Alere" iCup¿ Dx Drugs of Abuse Test (COC/THC)+(MET1000/OPI2000)+(MTD/TCA)+ (OXY/MDMA)+(PCP/AMP)+BAR+BZO With Cr, Ni, pH, Bl, S.G."
FDA Enforcement
Class II
·Terminated·Ameditech Inc·October 7, 2020
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
iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023
FDA Enforcement
Class III
·Terminated·Ameditech Inc·December 30, 2015
Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy
FDA Recall
Terminated
·ela Medical Llc·Product code NIK·June 7, 2010
LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233
FDA Recall
Terminated
·Esa Biosciences, Inc.·Product code DOF·May 19, 2005
ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142
FDA Recall
Terminated
·Esa Biosciences, Inc.·Product code DOF·September 20, 2007