101 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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 Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·September 28, 2017
Jazzy Select with XLR Port Harness
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code ITI·February 1, 2010
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code INI·November 26, 2010
Jazzy Select 6 with XLR Port Harness
FDA Recall
Terminated
·Pride Mobility Products Corp·Product code ITI·February 1, 2010
SmartSuction Harmony Powered Suction Device Model Number: HAR-E-115-US
FDA Recall
Terminated
·Haemonetics Corporation·Product code BTA·July 28, 2006
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
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
Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V
FDA Recall
Open, Classified
·Invacare Corporation·Product code ITI·March 30, 2022
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A. Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG
FDA Recall
Terminated
·Biosite Inc·Product code DKZ·April 27, 2009
7F ZUMA 2 JR 4.0 110CM Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Code: Z27JR40A
FDA Recall
Terminated
·Medtronic, Inc.·Product code DQY·April 5, 2006
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
FDA Recall
Open, Classified
·Siemens Medical Solutions USA, Inc·Product code OWB·March 26, 2021
Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8153, 2M8153R, 2M8163, 2M8163R
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·February 25, 2005
Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt.·Product code FRN·February 25, 2005
Japan DISP SET, 263J, 205J, HAR - Product Usage: its related accessory components are intended to be used for the recovery and processing of blood shed during or subsequent to an operation or as a result of trauma
FDA Recall
Terminated
·Haemonetics Corporation·Product code CAC·October 21, 2019
Invacare Lynx and Panther Scooters, motorized 3-wheeled vehicles.
FDA Recall
Terminated
·Invacare Corp·Product code ITI·February 10, 2003
Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays)
FDA Recall
Terminated
·Sunrise Medical Inc·Product code ITI·April 23, 2007