BEUDAMED
    66 results · 12ms · Sources: EU EUDAMED, US FDA

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    Human Fetal Hemoglobin (HBF-1) FITC Conjugate

    FDA Enforcement
    Class II ·Terminated·Life Technologies Corporation·April 25, 2018

    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 Enforcement
    Class III ·Terminated·Tosoh Bioscience Inc·April 17, 2013

    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

    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

    Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, single use cutting accessory intended for cutting an 11 mm diameter access hole through the cranium of adult patients. Catalog Number: 5100-060-001

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBF·October 16, 2020

    M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall

    FDA Recall
    Terminated ·New Wave Endo-Surgical, Corp.·Product code HCF·July 8, 2020

    Weck EFx Classic Fascial Closure System, Rx Only, Sterile, The product is intended to facilitate placement and withdrawal of suture loops to repair port side defects following laparoscopic surgery

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·March 24, 2016

    Weck Facial Closure Systems have application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

    FDA Recall
    Terminated ·Teleflex Medical·Product code HCF·November 16, 2016

    Box labeled in part, "REF: 72-1000***IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED***NON-STERILE PRODUCT*** MADE IN THE PHILIPPINES*** BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" The Biomet Microfixation IQ Intelligent Driver is a handheld cordless device designed for three functions: drill pilot holes, high-speed insertion of 1.5x4mm titanium screws, and high-speed insertion of 1.5x4mm and 1.5x5mm Lactosorb fixation screws provided by Biomet Microfixation. The IQ Intelligent Driver is indicated to aid in the implantation of screws (Drilling holes and inserting screws).

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code HBF·July 8, 2011

    STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

    FDA Recall
    Terminated ·HF Acquisition Co. LLC·Product code LRR·June 5, 2020

    STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC, 11629 49th Place West/Mukilteo, WA 98275, HealthFirst.com; Store at Room Temperature. 9036-2v.5 08/2017 containing various products to include Narcan Nasal spray, item number 1010300

    FDA Recall
    Terminated ·HF Acquisition Co., LLC·Product code LRR·June 4, 2020

    Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to securely immobilize the head and spine in the proper anatomical airway and spinal alignment. The occipital shape protects against positional plagiocephaly.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustable shock absorber and rotation with progressive stiffening -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) with female pyramid adapter 153 165mm (6 - 6 1/2) -Male pyramid adapter -Female pyramid adapter -Maintenance free, no lubrication required -Maximum weight: 147kg (325lbs) -Available in sizes 22-30

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·March 25, 2015

    Rebound Air Walker Product Usage: Rebound Air Walkers are indicated for grade 2 and grade 3 ankle sprains, to stabilize fractures, post-operative use, and trauma or rehab use.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016

    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.

    FDA Enforcement
    Class II ·Terminated·Ossur H / F·April 6, 2016