BEUDAMED
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    DURAHESIVE WAFER WITH FLANGE

    FDA 510(k)
    FDA Class 1 ·Gastroenterology, Urology

    n/a

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM510B8553140181·Rotary diamond instrument for dental application

    Cardio Clamp

    FDA UDI
    KOROS U.S.A., INC.·10840199535948·Long Jaw Cardio Clamp DeBakey Straight 18cm 7"

    NAR

    FDA UDI
    NORTH AMERICAN RESCUE, LLC·00842209137053·

    FG Dental Burs

    FDA UDI
    BIOLINE DENTAL IMPLANT SYSTEMS LTD·07290119311750·

    PowerBar

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746164828·FIXED FUNCT POWERBAR CLASS II 18MM UNIV 2/PK

    DAVOL ERCP CANNULA

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

    LASERSCOPE OMNIPLUS PHOTOSURGICAL SYS ND:YAG

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

    Johnson-Promident

    FDA UDI
    Young Innovations, Inc.·00843471109335·DIAMOND BUR 855 ROUND END TAPER 1.8MM DIAMETER ...

    ONYX VR

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code LWS·October 5, 2010

    INFUSOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code MEB·December 3, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 9, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017