BEUDAMED
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    Cellfina System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768499·GENUMEDI PSS GREEN V

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699571·GENUMEDI PSS BLUE, SIZE V

    ORTHOPEDIC SALVAGE SYSTEM (OSS)

    FDA UDI
    Biomet Orthopedics, LLC·00880304240179·

    AngioSystems Tray

    FDA UDI
    ANGIOSYSTEMS, INCORPORATED·00816611026458·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100158·KRATZ-BARRAQUER SPECULUM LARGE

    DEPOTONE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FRESENIUS 2008T HEMODIALYSIS MACHINE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ESON 2 NASAL MASK

    FDA Adverse Event
    Injury ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZD·August 14, 2019

    Suprathel®

    FDA UDI
    Polymedics Innovations GmbH·04260184021130·Suprathel® is an absorbable, microporous membra...

    ACUMATCH GXL 15DEG LINER 28MM SZ G

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 23, 2022

    PRIMEADVANCED

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 6, 2013

    2-L HUB CONNECT ASSY REPLACEMENT SET

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code NFK·June 22, 2011

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·September 4, 2008

    SYNCHROMED EL

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 12, 2016

    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 00643169529533) and REF 9735502-G02 (GTIN 00763000208462); Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169540521); and Medtronic Adapter Percutaneous Pin Kit, REF 9734752K (GTIN 00643169641006) (Japan). The percutaneous pin adapter is a component of the StealthAir Frame Assembly.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·December 25, 2019

    Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 8, 2026

    Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5; Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP; Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP; Immutest 5 panel, Item No. IMCA-5AB-W; Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W; Immutest 7 panel, Item No. IMCA-7P; ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of these Drugs of Abuse Tests consist of a combination of drug strips, including Benzodiazepine (BZO). They are used to obtain a visual, qualitative result and are intended for professional and point of care use. ¿¿¿

    FDA Enforcement
    Class II ·Terminated·Ameditech Inc·November 25, 2015

    Vaxcel Plus Chronic Dialysis Catheters - Kit/CPU/15/50/Metal Catalog Number: 45-558

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code KOB·July 22, 2005