BEUDAMED
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    CLAVEGUARD FREEDOM SURGICAL LIGHT

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

    Equator

    FDA UDI
    Preat Corporation·00842092179970·Equator Abutment for Nobel Active/Conical RP x 2mm

    Suprasorb

    FDA UDI
    Huizhou Foryou Medical Devices Co., Ltd.·06940610115708·

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·10840200300541·SUTURE REMOVAL

    E.M Adams co, inc.

    FDA UDI
    E.M. ADAMS, INC.·18100013400541·SUTURE REMOVAL

    LIQUIBAND DUAL, MODEL LBD 001

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

    FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5

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

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·October 4, 2014

    PROLENE POLYPROPYLENE MESH

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code FTL·June 3, 2013

    AUTOTOME RX SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code KNS·June 28, 2011

    AERO LL FIXATION ANCHOR, 50MM

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code OVD·March 25, 2019

    OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Osteomed, LLC·June 10, 2020

    OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities, spine, pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Callos Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.

    FDA Enforcement
    Class II ·Terminated·Skeletal Kinetics, Llc·July 22, 2020

    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

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026