193 results
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13ms
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Sources: EU EUDAMED, US FDA
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions.
FDA Recall
Terminated
·Argo Medical Technologies Ltd Matambuilding 30p.O.Box·Product code PHL·February 28, 2020
ReWalk Personal 6.0. Catalog number: 50-20-0004.
FDA Recall
Terminated
·Argo Medical Technologies Ltd Matambuilding 30p.O.Box·Product code PHL·August 14, 2017
VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
FDA Recall
Terminated
·bioMerieux·Product code LJC·August 6, 2003
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·July 18, 2006
APhL HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360-- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. --(current address now in Seabrook, TX 77586).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·October 6, 2005
APhL HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc.-- (current address now in Seabrook, TX 77586).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·October 6, 2005
APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360- Quality Control Fact Sheets for the Louisville APL Diagnostics, Inc. (address now in Seabrook, TX 77586).
FDA Recall
Terminated
·Louisville Apl Diagnostics Inc·Product code MID·October 6, 2005
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
FDA Recall
Terminated
·Northgate Technologies, Inc.·Product code FFK·May 24, 2017
Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code MID·June 22, 2001
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
FDA Recall
Terminated
·Zeus Scientific Inc·Product code DHR·November 9, 2001
Rubella IgM ELISA Test Kit. It is an enzyme-linked immunoabsorbent assay designed for the qualitative detection of IgM antibodies to Rubella virus in human serum. 1 kit (96 tests). Prepared for Sigma Diagnostics, Inc., St. Louis, MO 63178. EIA514-B
FDA Recall
Terminated
·Zeus Scientific Inc·Product code LFX·February 24, 2000
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
FDA Recall
Terminated
·Zeus Scientific Inc·Product code LJB·March 19, 2001
Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
Alsius CoolGard Temperature Regulation System
FDA Recall
Terminated
·Alsius Corporation·Product code NCX·November 9, 2005
Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016
PML --IDS Rapid NH QC Set- Quality Control kit for culture media. Product label includes LyfoCults IVD , Lot # 134-1 Exp 02AUG2008. PML Micrcobiologicals 27120 SW 95th Avenue Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
PML -- Vitek NH ID Card (NHI) Set - Quality Control kit for culture media. Each kit includes a 5 pack of LyfoCults Haemophilus parainfluenzae - Lot # 185-1 Exp 13AUG2008. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
PML -- LyfoCults Haemophilus parainfluenzae - micro organism. Product label includes LyfoCults Haemophilus parainfluenzae ATCC 7901 Lot No.: 233851-1 Exp 05-17-09. PML Micrcobiologicals, 27120 SW 95th Avenue, Wilsonville, Oregon 97070
FDA Recall
Terminated
·PML, Inc. dba Pml Microbiologicals Inc.·Product code JTR·October 15, 2007
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
FDA Recall
Terminated
·Villa Sistemi Medicali S.P.A. Via delle Azalee·Product code KXJ·December 27, 2016