BEUDAMED
    13 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·January 30, 2013

    All brochures printed before November 20, 2013 for the HyperBlue 1530 medical laser, including the product brochure and the online information regarding the product at www.hyperionMed.com before December 3, 2013.

    FDA Enforcement
    Class II ·Terminated·Hyperion Medical·August 27, 2014

    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·June 15, 2016

    Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    epoc BGEM Test Card (Catalogue number CT-1004-00-00). quantitative testing of samples for pH, pCO2, pO2, Sodium Potassium , Ionized Calcium, Glucose, Lactate and Hematocrit.

    FDA Enforcement
    Class II ·Terminated·Epocal·August 21, 2013

    Orbit soft Infusion sets, 9 mm soft cannula, P10 (42") tubing; Single-Use Set Orbit Infusion Sets are sterile, non-pyrogenic, single-use devices intended to be used for subcutaneous delivery of medication , for example insulin, from an external infusion pump.

    FDA Enforcement
    Class II ·Terminated·Perrigo Diabetes Care·February 26, 2014

    Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion

    FDA Enforcement
    Class II ·Terminated·Ebi, Llc·December 4, 2013

    BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA*** Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·February 6, 2013

    Major Ortho Pack, kit number 002647-12 and 002647-13 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. The recall was expanded on December 20, 2013 to include the following devices: rHead lateral assembly, radial head implant, sizes 2 through 4, Uni-elbow lateral assembly, radial implant assembly, sozes 2 through 4, ReMotion Left, large distal radial component, x-small, small, medium, and large, ReMotion Right, distal radial component, x-small, small, medium, and large.

    FDA Enforcement
    Class II ·Terminated·Small Bone Innovations, Inc.·November 6, 2013

    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·February 12, 2014

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016