BEUDAMED
    11 results · 20ms · 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 Regulation: Us FDA ×

    Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·June 15, 2016

    AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP

    FDA 510(k)
    FDA Class 2 ·Neurology

    ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FMI·November 30, 2016

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 4, 2016

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 6, 2014

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 2, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 17, 2013

    UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

    FDA Enforcement
    Class II ·Terminated·Zimmer Surgical Inc·November 12, 2014

    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used to isolate tissue and/or act as a containment system during surgery. It is provided in a variety of sizes and has applications in the Urology, Surgery, and Reproductive Health business units.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·July 1, 2015