BEUDAMED
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    DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964014725·The ENDO CARRY-ON Procedure Kit contains all of...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001602·artVeneer life upper anteriors, BOM, BL3

    SCANLAN® A/V Punch

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159000863·SCANLAN® A/V Punch, 4.0 mm

    Health-Tec/DHP Hand Instruments

    FDA UDI
    Dental Health Products Inc·D77370016020·Health-Tec/DHP Probe Michigan 'O' (3-6-8mm)

    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

    FDA Recall
    Open, Classified ·Physio-Control, Inc.·Product code MKJ·September 29, 2023

    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·November 22, 2023

    4.0 X 16mm CANN SCREW FASTENER Ti LG THD

    FDA UDI
    Osteocentric Technologies, Inc.·00810074303415·4.0 X 16mm CANN SCREW FASTENER Ti LG THD

    PROTEGE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    WAKO LIPASE CALIBRATOR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 3, 2025

    TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNIVERS II REAMER, 8MM - HUDSON CONNECT

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code MDM·May 22, 2024

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·March 13, 2013

    TRUFILL DCS ORBIT MINI COMPLEX FILL

    FDA Adverse Event
    Injury ·CORDIS NEUROVASCULAR, INC.·Product code HCG·February 25, 2011

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITJ·August 12, 2014

    INSET

    FDA Adverse Event
    Malfunction ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·March 30, 2026

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013