24 results
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31ms
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Sources: EU EUDAMED, US FDA
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Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
FDA Recall
Terminated
·Anjon Holdings·Product code JEC·June 18, 2020
Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
FDA Recall
Terminated
·Canon Inc. 30-2, Shimomaruko 3-chome, Ohta-ku Tokyo Japan·Product code MQB·November 1, 2010
DEX Ophthalmic Tissue Forceps, 25ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-25
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-27
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX NanoTapered AWH Forceps, Model/Catalog Number: DVF4005-23
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Super Grip Forceps, Model/Catalog Number: DVF4034-25
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
BACTEC(tm) MGIT(tm) 5-Tube Spare AST Set Carrier, Bag of 3, Catalog 445943. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010
BACTEC(tm) MGIT(tm) AST Label Spares, Catalog 445959. Kit contains Contains 5 each of the 5-Tube and 2-Tube Barcoded Labels. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010
BACTEC(tm) MGIT(tm) 2-Tube Spare AST Set Carrier, Bag of 3, Catalog 445946. ***Becton, Dickinson and Company, 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010
BACTEC(tm) MGIT(tm) AST Starter Kit, Catalog 445941. Kit contains 16 each of the 5-Tube and 2-Tube Set Carriers. ***Becton, Dickinson and Company 7 Loveton Circle Sparks, Maryland 21152*** The BACTEC MGIT AST system is a rapid qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture, to streptomycin, isoniazid, rifampin, ethambutol, and pyrazinamide. The routine AST set consists of a Growth Control tube and one tube for each drug, as well as a barcoded tube carrier that holds the set. The barcode provides set size and identification. A tube rack capable of holding up to 55 AST tubes in various set combinations is available for tube setup and transport. (Large or small AST carrier sets can be placed in the rack also.) The MGIT AST system is based on growth of the Mycobacterium tuberculosis strain under test as measured by the instrument. AST sets are entered into the BACTEC MGIT 960 instrument and are tested automatically. Analysis of fluorescence in a drug containing tube is compared to the fluorescence of the Growth Control tube to determine susceptibility results.
FDA Recall
Terminated
·Becton Dickinson & Co. BD Diagnostic Systems·Product code MJA·August 31, 2010
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Serrated Forceps, Model/Catalog Number: DVF4016-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Nano Tapered AWH Forceps, Model/Catalog Number: DVF4005-25
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 23ga DEX Maculorhexis Forceps, Model/Catalog Number: DVF4019-23
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
FDA Recall
Terminated
·Elite Biomedical Solutions LLC·Product code FRN·June 3, 2015
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
FDA Recall
Terminated
·Roche Molecular Systems, Inc.·Product code JJF·February 1, 2012
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
FDA Recall
Terminated
·Elite Biomedical Solutions LLC·Product code FRN·June 3, 2015
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53
FDA Recall
Open, Classified
·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·September 20, 2018
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026
DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Asymmetrical Tano Forceps, Model/Catalog Number: DVF4014-25-S
FDA Recall
Open, Classified
·Katalyst Surgical, LLC·Product code HNR·March 25, 2026