BEUDAMED
    21 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Iii × Clear all

    Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-21 Vial Labels: Mat. No K589911-21512

    FDA Enforcement
    Class III ·Ongoing·Agilent Technologies, Inc.·July 20, 2022

    AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

    FDA Enforcement
    Class III ·Terminated·Applied Medical Technology Inc·December 30, 2020

    20545 Vitale Silver calcium Alginate Dressings 4x5, 10/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20548 Vitale Silver calcium Alginate Dressings 4x8, 5/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20544 Vitale Silver calcium Alginate Dressings 4x4, 10/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20500 Vitale Silver calcium Alginate Dressing Ropes, 5/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    20522 Vitale Silver calcium Alginate Dressings 2x2, 10/box

    FDA Enforcement
    Class III ·Terminated·CellEra LLC·March 23, 2022

    LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.

    FDA Enforcement
    Class III ·Terminated·CooperSurgical, Inc.·September 25, 2019

    Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

    FDA Enforcement
    Class III ·Terminated·Remel Inc·December 25, 2013

    Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

    FDA Enforcement
    Class III ·Terminated·C.R. Bard, Inc.·November 11, 2015

    iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch pouches/box. Dosage: 120mA/min.

    FDA Enforcement
    Class III ·Terminated·Tapemark Company·January 12, 2022

    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.

    FDA Enforcement
    Class III ·Terminated·Steris Corporation·September 12, 2012

    Dermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

    FDA Enforcement
    Class III ·Terminated·National Biological Corp·July 31, 2013

    Dermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.

    FDA Enforcement
    Class III ·Terminated·National Biological Corp·July 31, 2013

    Wallace Artificial Insemination Catheter, 180 mm, Sterile, Quantity: 1 Box (10 units), Model: AIC18JP, Cooper Surgical Inc., (01) 2 0888937 021749 - Product Usage: Intended use of the product is the introduction of washed spermatozoa into the uterine cavity.

    FDA Enforcement
    Class III ·Terminated·CooperSurgical, Inc.·April 22, 2020

    MedTest DX Assayed Human Multi Sera Control Level 1 (HNC200) and Level 2 (HEC200) HEC200 " Sml amber glass vial with rubber stopper and black plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. HNC200 " Sml amber glass vials with rubber stopper and green plastic screw cap. " 1 0 control vials per box, 12 cell foam insert. Product Usage: MedTest DX Controls Level 1 and 2 is lyophilized human based control sera for use in the quality control of diagnostic assays. Human sera can be supplied as an assayed serum for control of accuracy or as a precision serum for control reproductivity. Concentration are available in 2 levels, normal (HNC) and elevated (HEC).

    FDA Enforcement
    Class III ·Terminated·Medtest Holdings, Inc.·June 14, 2017

    VITROS Immunodiagnostic Products Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.

    FDA Enforcement
    Class III ·Terminated·ORTHO-CLINICAL DIAGNOSTICS·June 10, 2015

    Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette, Model 10-991. Product Generic Name: Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette. Description of the product: Lipid. Glucose panel Test cassettes. Product packaging: 10 individually pouched cassettes in a labeled kit box. Intended for the quantitative determination of total cholesterol, HDL (high-density lipoprotein) cholesterol, triglycerides, and/or glucose in whole blood, serum, and plasma.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·December 4, 2013

    LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

    FDA Enforcement
    Class III ·Terminated·Alere San Diego, Inc.·September 21, 2016

    VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length, and available in three sizes: 0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU.

    FDA Enforcement
    Class III ·Terminated·Lacrimedics Inc·February 18, 2015