98 results
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13ms
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Sources: EU EUDAMED, US FDA
Sleeve, Product Number Sleeve, Part Numbers RESL, SL 3 L, SL 3 M, SL 3 S, L 3 X, SL 3 XS, UESL Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.
FDA Recall
Terminated
·Burlington Medical, LLC·Product code EAJ·June 7, 2019
Becton Dickinson's ProbeTec (tm) ET Instrument
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code LSL·July 21, 2003
Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568, Catalog GXCT/NG-10 Batch 1000053075, Catalog GXCT/NG-10 Batch 1000056156 and Catalog GXCT/NG-10 Batch 1000056157. Is a qualitative in vitro real-time PCR test.
FDA Recall
Terminated
·Cepheid·Product code LSL·October 9, 2017
Amplicor [3] AV-HRP. (Avidin-HRP (Horseradish Peroxidase) BGG Conjugate.) Kit: Amplicor CT/NG NG Detection Kit
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code LSL·July 7, 2004
Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG Urine Specimen Collection Kit is designed to preserve and transport Chlamydia trachomatis and Neisseria gonorrhoeae DNA in first-catch male and female urine specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
FDA Recall
Terminated
·Cepheid·Product code LSL·July 27, 2015
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiology: The Cepheid X pert CT /NG Vagina Endocervical/ Specimen Collection Kit is designed to collect, preserve and transport patient Chlamydia trachomatis and Neisseria gonorrhoeae DNA in endocervical and vaginal specimens from symptomatic and asymptomatic individuals prior to analysis with the Cepheid Xpert CT/NG Assay.
FDA Recall
Terminated
·Cepheid·Product code LSL·July 27, 2015
BD ProbeTec ET Urine Processing Kit, 4x25, catalog 440454, packaged in a carton containing 4 storage bags identified as BD ProbeTec ET Urine Processing Pouches, 25 pouches/bag. Carton and bags labeled in part ***Becton, Dickinson and Company, 7 Loveton Circle, Sparks, MD 21152***
FDA Recall
Terminated
·Becton Dickinson & Co.·Product code LSL·January 10, 2005
Amplicor [3] AV-HRP, Avidin-HRP Horseradish Peroxidase) BGG Conjugate. Kit: AMPLICOR NG Detection Kit, Export IVD/CE.
FDA Recall
Terminated
·Roche Molecular Systems Inc·Product code LSL·July 7, 2004
InteliFUSE, Drill Bit, 2.00 mm, J-Latch, QTY: 1, REF: DB.200.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom Intended Use: Creating of holes for implant placement.
FDA Recall
Terminated
·Intelifuse Inc·Product code HTW·July 30, 2008
InteliFUSE, Drill Bit, 1.50 mm, J-Latch, QTY: 1, REF: DB.150.JL, non-sterile, 1515 Poydras st., Ste 1490, New Orleans, LA 70112, MDCI Arundel House, 1 Liverpool Gardens, Worthing, West Sussex BN11 1SL, United Kingdom Intended Use: Creating of holes for implant placement.
FDA Recall
Terminated
·Intelifuse Inc·Product code HTW·July 30, 2008
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position to another, and to elevate a patient for toileting, repositioning, changing of incontinence pads or wound dressings, standing practice etc. it is not intended for long periods of suspension or transportation.
FDA Recall
Terminated
·Arjo, Inc. dba ArjoHuntleigh·Product code FSA·June 29, 2012
Pathfast D-Dimer, Reference number: PF1051-KUS
FDA Recall
Terminated
·Lsi Medience Corporation 13-4 Uchikanda·Product code GHH·August 16, 2016
SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/Product Code OQIM 13, Siemens Material Number (SMN)10446073
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017
Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System.
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code LPS·May 17, 2016
SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T Protein Control SL/L: REF/Product Code OQIN19, SMN 10446079 (Low); N/T Protein Control SL/M, REF/Product Code OQIO19, SMN 10446085 (Mid); N/T Protein Control SL/H, REF/Product Code OQIP19, SMN 10446089 (High);
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code CHN·June 5, 2017
Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997
FDA Recall
Terminated
·CSL Behring GmbH Emil-Von-Behring-Str. 76 Marburg Germany·Product code NAO·March 2, 2020
N Latex CDT Kit
FDA Recall
Terminated
·CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany·Product code NAO·May 31, 2018
FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code LFL·November 25, 2003
HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LFL·March 16, 2012