BEUDAMED
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    GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Preclean Kit

    FDA UDI
    MEDIVATORS INC.·40677964010666·Preclean Plus Kit includes Brush, DEFENDO Olymp...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040129814·Needle Holder Olsen-Hegar

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001125·artVeneer life lower anteriors, UBS, A35

    Immunalysis Corporation

    FDA UDI
    IMMUNALYSIS CORP·00840937107980·Immunalysis Corporation cTHC Urine Calibrator L...

    BOTANIQ

    FDA UDI
    Inspecs U.S.A., L.C.·00841543148343·SUNGLASS

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 10, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·March 10, 2025

    LIFECARD CF COMPACT RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JET PORT PLUS CATHETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 2, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 24, 2025

    TUFF IMPLANT

    FDA Adverse Event
    Injury ·NORIS MEDICAL LTD·Product code DZE·November 24, 2025

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 26, 2013

    ARSTASIS ACCESS SYSTEM

    FDA Adverse Event
    Other ·ARSTASIS, INC.·Product code DYB·February 17, 2011

    U0707 ARENA MACHINE 2 PUMPSWITH NIBP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION- LARGO·Product code KDI·February 15, 2008

    VERCISE GENUS?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·February 20, 2026

    Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·July 16, 2014

    PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

    FDA Enforcement
    Class II ·Ongoing·TEI Biosciences, Inc.·July 12, 2023

    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication functions for the Pulse Generator (PG). Detailed software applications instructions can be found in the associated product literature for the PG being interrogated.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific Corporation·October 3, 2018