387 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Enforcement
Class II
·Terminated·Tosoh Bioscience Inc·December 19, 2018
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·September 28, 2017
EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1
FDA Enforcement
Class II
·Terminated·NDDd Medical Technologies, Inc.·December 11, 2019
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code INI·November 26, 2010
Nuvasive NVM5 EMG Module, REF 8020015, Rx ONLY, CE2797, Nonsterile, UDI: 00887517206633 - Product Usage: is intended for intraoperative neurophysiologic monitoring during spinal surgery.
FDA Enforcement
Class II
·Terminated·NuVasive Inc·July 29, 2020
EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1
FDA Enforcement
Class II
·Terminated·NDDd Medical Technologies, Inc.·December 11, 2019
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Enforcement
Class I
·Terminated·STEP-HAR MEDICAL LLC·May 19, 2021
Mamoray HDR-C PLUS Mammography film
FDA Recall
Terminated
·AGFA Corp.·Product code IWZ·February 16, 2006
Jazzy Select with XLR Port Harness
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code ITI·February 1, 2010
Jazzy Select 6 with XLR Port Harness
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code ITI·February 1, 2010
Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Park, Upper Dunmurry Lane, Belfast, United Kingdom; Distributed by Patterson Medical; sold as replacement belts and as a component of the following adjustable mechanical chairs: a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193
FDA Recall
Terminated
·Patterson Medical Holdings, Inc.·Product code INN·April 17, 2009
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
FDA Recall
Terminated
·Haemonetics Corporation·Product code BTA·July 28, 2006
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
FDA Enforcement
Class II
·Terminated·Pride Mobility Products Corp·July 11, 2012
Alaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair part
FDA Recall
Terminated
·STEP-HAR MEDICAL LLC·Product code FRN·February 26, 2021
Access Hi-Low Exam Tables, Model 6501-XX
FDA Enforcement
Class II
·Terminated·Brewer Company, LLC·August 1, 2018
Alpha-Omega Services, Inc. Product No: NFV0003-003 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 20CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0003-003. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0001-004. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method.
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code IWJ·November 15, 2007
Nucletron Adapter and Transfer Guide Tube, part number AL 13005000, a component used with the VariSource" IX HDR Afterloader. Product Usage: The adapter is part of the VariSource Afterloader System, a computer controlled remote HDR Afterloader used to place a high activity radioactive source within a needle(s) or applicator(s) which have previously been placed for a specific clinical purpose in a patient.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code JAQ·January 5, 2012
TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable
FDA Recall
Terminated
·Alpha Omega Services Inc·Product code JAQ·February 21, 2006
Siemens Artis Q and Artis Q biplane systems Product Usage: Interventional Fluoroscopic X-ray
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 2, 2014