BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    SILIMED NASAL RETAINER

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    EA STIMULATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    QUATRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 22, 2013

    HYPERGLIDE OCCLUSION BALLOON SYSTEM

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code MJN·August 5, 2014

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·February 1, 2011

    Angiotech Soft Tissue Biopsy Needle Core: A) Pro-Mag "Short Throw" Biopsy Needle, and Pro-Mag Biopsy Needle. STERILE. Product Number: 765114080, 765116120, 765114120, 765118080, 765118120, 765014100, 765014120, 765016100, 765018100. 510k K980226. Qty Dist - 37,880. B) Tru-Core I Biopsy Needle, STERILE. Product Number: 763314100, 763316100, 763318100. 510k K990839. Qty Dist. - 1,010. C) UltraCORE Biopsy Needle. STERILE. Product Number: 762614100, 762614130, 762616100, 762616130, 762618100. 510k K921418. Qty Dist - 12, 550. D) SACN Biopsy Needle. STERILE. Product Number: SACN1608MF, SACN1808MF. 510k K980226. Qty Dist. - 580. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Soft Tissue Biopsy Needle Core

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

    FDA Enforcement
    Class I ·Ongoing·American Contract Systems, Inc.·July 13, 2022

    COVID Test Kit Nonsterile

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·October 19, 2022

    COVID Test Kit Nonsterile

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code JSM·August 12, 2022

    Angiotech Galactography Kit. Galactography Kit 30ga with Straight Cannula and Galactography Kit 30ga with Curved Cannula. STERILE. Product Number: DGK002SX, DGK002X. 510k K980227. Qty Dist. - 2,630. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Injection Media Contrast Kit Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code FMI·September 1, 2009