BEUDAMED
    16 results · 23ms · Sources: EU EUDAMED, US FDA

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    Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    XENMATRIX

    FDA UDI
    Davol Inc.·00801741074172·XenMatrix AB Surgical Graft, 6 cm x 6 cm

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100172·KRATZ WIRE SPECULUM WITH WINGS

    HNM Women Care

    FDA UDI
    HNM STAINLESS, LLC.·00812171028215·PESSARY, DONUT #1, 2.25"

    VATEA ENDONTIC IRRIGATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Dental

    SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL)

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 25, 2024

    VENTED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2016

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·June 6, 2013

    OT VERIO TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 8, 2014

    BARD FLAT MESH

    FDA Adverse Event
    Injury ·DAVOL INC.·Product code FTL·June 23, 2011

    TREVO XP PROVUE 4MM X 30MM

    FDA Adverse Event
    Injury ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code NRY·July 24, 2020

    EDI BZO UNCUT SHEET-CARD, Item No. 100170 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

    Ruggles Leyla Ball Joint Clamp, MODEL/CATALOG #: R2383 . The Leyla Ball Joint Clamp is part of the Table Mounting Hardware that is used with the Leyla Retractor System. The Leyla Table Mounting Hardware consists of the Ball Joint Clamp, the Rigid Holding Rod, the Coupling Head, and the Coupling Head Turn Table. The Ball Joint Clamp is available individually or as part of the Table Mount Set. The Table Mounting Hardware are attachments to operating room surgical tables. The product is supplied non-sterile and may be packaged individually or as part of the Table Mount Set.

    FDA Recall
    Terminated ·J. Jamner Surgical Instruments, Inc.·Product code FWZ·April 24, 2006