BEUDAMED
    66 results · 6ms · 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 Classification: Class Ii × Status: Terminated × Clear all

    BD Precision Glide Needle 18G x 1 RB, Catalog 305195 Product Usage: These needles are intended for general purpose fluid injection/aspiration, infusion, venipuncture to obtain blood collection and insulin injection.

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Company·December 13, 2017

    SB Knife -Electrosurgical Knife, Sterile Size: Working Length 2.3M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Enforcement
    Class II ·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016

    SB (Sumitomo Bakelite Co.,) Electrosurgical Knife Size: Working Length 1.8M Maximum OD 2.6mm. Product Usage: The SB Knife is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.

    FDA Enforcement
    Class II ·Terminated·Akita Sumitomo Bakelite Co., Ltd.·November 16, 2016

    EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000 The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the instrument. PN 410322-05

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·March 4, 2015

    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.

    FDA Enforcement
    Class II ·Terminated·SALTER LABS·July 4, 2012

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·July 30, 2014

    NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or homecare environment.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·September 23, 2015

    Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road, Arvin, CA 93203. CO2 sample line.

    FDA Enforcement
    Class II ·Terminated·SALTER LABS·November 27, 2013

    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·February 17, 2016

    EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·October 22, 2014

    EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

    FDA Enforcement
    Class II ·Terminated·Intuitive Surgical, Inc.·March 4, 2015

    Medivators EndoGator REF 100651. Kit for Olympus 140/160/180/190 Series GI Endoscopes for CO2 Connection with Endogator EGP-100, Olympus OFP, Olympus AFU-100 & Erbe EIP 2 Irrigation Pump Units. Contents 10. Sterile EO. of 100145CO2EXT Endo SmartCap Irrigation Tubing for Olympus 140/160/180/190 Series GI Endoscopes with Extended CO2 Input - Product Usage: is intended to be used with an air or CO2 source and/or a pump along with a sterile water source to supply air or CO2 and sterile water to an endoscope during endoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Medivators, Inc.·April 29, 2020

    Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.

    FDA Enforcement
    Class II ·Terminated·Wexford Labs Inc·November 27, 2013

    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

    FDA Enforcement
    Class II ·Terminated·Lab Vision Corporation·January 22, 2014

    miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for the permanent removal of underarm hair.

    FDA Enforcement
    Class II ·Terminated·Miramar Labs, Inc.·November 18, 2015

    AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL, (01)00853592008219 - Product Usage: intended for the qualitative detection of IgM antibodies in serum collected from the individuals suspected with signs and symptoms of COVID-19 infection by their healthcare provider.

    FDA Enforcement
    Class II ·Terminated·Ansh Labs, LLC·January 20, 2021

    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.

    FDA Enforcement
    Class II ·Terminated·Heritage Labs International LLC·April 24, 2013

    Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    FDA Enforcement
    Class II ·Terminated·Hand Biomechanics Lab Inc·October 26, 2016

    BAUSCH + LOMB Biotrue ONEday lenses (nesofilcon A), Product Order Number Biotrue SVS - 7201, STERILE, Rx Only; The lenses are available in 5 pack, 30 pack and 90 pack sizes; Biotrue ONEday Foil - Part Number 8098001, Biotrue ONEday 5 pack Carton International - Part Number 8101403, and Biotrue ONEday 90 pack Carton International - Part Number 8098203.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc Irb·November 11, 2015

    PeroxiClear Peroxide Solution, (3oz. and 12 oz., 12 oz. Twin Pack, 2x12 oz. Twin Pack for Target stores, 12 oz. for Walmart Vision Center and 3 oz. Starter Kit US), Manufactured by Bausch + Lomb, Rochester, NY 14609. PeroxiClear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses.

    FDA Enforcement
    Class II ·Terminated·Bausch & Lomb Inc Irb·November 30, 2016