BEUDAMED
    92 results · 19ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall ×

    Medtronic Grafton DBF: a) PUTTY T50101 GRAFTON DBF 1CC, REF T50101; b) PUTTY T50101INT GRAFTON DBF 1CC, REF T50101INT; c) PUTTY T50103 GRAFTON DBF 3CC, REF T50103; d) PUTTY T50103INT GRAFTON DBF 3CC, REF T50103INT; e) PUTTY T50106 GRAFTON DBF 6CC, REF T50106; f) PUTTY T50106INT GRAFTON DBF 6CC, REF T50106INT; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

    COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S

    FDA Recall
    Terminated ·Wilson-Cook Medical Inc.·Product code FFF·December 18, 2018

    Medtronic Grafton DBF Inject: a) GRAFTON T50303 DBF INJECT 3CC, REF T50303; b) GRAFTON T50306 DBF INJECT 6CC, REF T50306; c) GRAFTON T50309 DBF INJECT 9CC, REF T50309; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    Medtronic Accelerate Grafton DBF a) ACCELERATE BG SET T50203 GRAFTON DBF 3CC, REF T50203; b) ACCELERATE BG SET T50206 GRAFTON DBF 6CC, REF T50206; c) ACCELERATE BG SET T50209 GRAFTON DBF 9CC, REF T50209; d) ACCELERATE BG SET T50212 GRAFTON DBF12CC, REF T50212; Demineralized Bone Matrix (DBM) product

    FDA Recall
    Open, Classified ·Medtronic Sofamor Danek USA Inc·Product code MBP·February 8, 2023

    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Recall
    Terminated ·Life Technologies Corporation·Product code GHQ·February 7, 2018

    G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.

    FDA Recall
    Terminated ·Tosoh Bioscience Inc·Product code JPD·August 18, 2010

    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017

    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·August 22, 2017

    VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

    FDA Recall
    Terminated ·Bio-Rad Laboratories, Inc.·Product code LCP·September 12, 2011

    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.

    FDA Recall
    Terminated ·PF Consumer Healthcare 1 LLC·Product code IMD·April 26, 2019

    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.

    FDA Recall
    Terminated ·PF Consumer Healthcare 1 LLC·Product code IMD·April 26, 2019

    37% Etching Gel-3ml syringe, part #N01H The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.

    FDA Recall
    Terminated ·Kerr/pentron Dba Kerr Corporation And Pentron Clinical·Product code EBF·March 31, 2011

    PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental composite

    FDA Recall
    Terminated ·Kerr Corp·Product code EBF·September 5, 2008

    Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

    FDA Recall
    Terminated ·Ivoclar Vivadent, Inc.·Product code EBF·August 3, 2017

    Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog Number: 4817- Software Version: N/A Product Description: Transcend universal composite is a light-cured, tooth shade resin composite material (Bis-GMA-based) to be used for direct and indirect posterior and anterior tooth restorations. Transcend universal composite is radiopaque and available in a range of dentin, enamel, and body shades. It is 79% filled by weight and 60-61% filled by volume and has an average particle size of 0.9 m (by weight) with narrow upper limit particle distribution. Component: N/A

    FDA Recall
    Open, Classified ·Ultradent Products, Inc.·Product code EBF·August 2, 2024