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

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    AUTO REF/KERATOMETER ARK-1s

    FDA Recall
    Terminated ·Nidek Inc.·Product code HKO·December 20, 2017

    AUTO REF/KERATOMETER ARK-1s

    FDA Enforcement
    Class II ·Terminated·Nidek Inc.·April 18, 2018

    Widefield OCT software feature for the Spectralis HRA+OCT and variants

    FDA Enforcement
    Class II ·Terminated·Heidelberg Engineering·May 2, 2018

    HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hammond Road St Paul, MN 55110, Part Number HMK-RM

    FDA Recall
    Terminated ·Porous Media Corporation·Product code BTT·April 26, 2007

    Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003

    FDA Enforcement
    Class II ·Terminated·Kelyniam Global, Inc.·May 23, 2018

    12 French 3 Lumen 20 cm Large-Bore Central Venous Catheters. Product numbers AK-15123-H, AK-15123-J, CS-15123-E, and MC-15123. The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FOZ·May 8, 2009

    Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures.

    FDA Recall
    Terminated ·Ormco Corporation·Product code EKM·September 9, 2010

    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.

    FDA Enforcement
    Class II ·Terminated·Summit Medical, Inc.·December 23, 2015

    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJK·February 27, 2015

    Cooper Surgical CANNULA-CURETTE 12MM; Model Number: MX562 The CooperSurgical SUCTION CANNULA-CURETTE device is used to remove tissue from within the uterine cavity on an outpatient basis. The primary uses for this device are for endometrial sampling especially of those patients with a higher risk of cancer. The curettes must be used with a suction pump, as well as sterile tubing, and a swivel handle. The rigid plastic suction curette is sterile and disposable. The Cannula Curette is available in the following styles: Long Curved, Long Straight, and Short Curved.

    FDA Recall
    Terminated ·CooperSurgical, Inc.·Product code HHK·October 27, 2014

    An endometrial suction curette is a device used to remove material from the uterus and from the mucosal lining of the uterus by scraping and vacuum suction. This device is used to obtain tissue for biopsy or for menstrual extraction. This generic type of device may include catheters, syringes, and tissue filters or traps sold under the Medline Industries, Boss Instruments, Symmetry Surgical, CareFusion, and Adler Instrument Company brand names.

    FDA Recall
    Terminated ·Instrumed International, Inc.·Product code HHK·September 8, 2014

    Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, and peripheral retina) and use in the therapy of intraocular abnormalities

    FDA Recall
    Terminated ·Volk Optical Inc·Product code HJK·February 2, 2016

    Gold Hub Finesse Cannula, Catalog Nos. HK10F23; HK12F10; HK12F15; HK12F23; HK14F10; HK14F15; HK14F23; HK16F5; HK16F8

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004

    Gold Hub Capistrano Cannula, Catalog Nos. HK10C15; HK10C23;HK12C15;HK12C23: HK14C15; HK14C23; HK16C5; HK16C8; HK16C12; HK16C15; HK18C8; HK18C6

    FDA Recall
    Terminated ·HK Surgical Inc·Product code FIE·December 3, 2004