BEUDAMED
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    BM3/BM3 PLUS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Oticon

    FDA UDI
    Oticon A/S·05707131256980·NERA PRO, MINIRITE 312 WL CBE DEMO

    NexxZr™ T / D-100-35-NT-A300-SD

    FDA UDI
    SAGEMAX BIOCERAMICS, INC·00842271112439·

    ihcDirect® Cytokeratin 19 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596450·Clone R1002

    ihcDirect® Cytokeratin 19 Ab

    FDA UDI
    NOVODIAX, INC.·00850000596443·Clone R1002

    ihcDirect® Cytokeratin 19 Ab Conjugate 15mL

    FDA UDI
    NOVODIAX, INC.·00850030934208·Clone R1002

    ihcDirect® Cytokeratin 19 Ab Conjugate 5mL

    FDA UDI
    NOVODIAX, INC.·00850030934192·Clone R1002

    NON AC-POWERED PATIENT LIFT

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code FSA·August 21, 2013

    COMBITRANS MONITORING SETS AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SERVO-I BASE UNIT

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 4, 2024

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013

    ASKU

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA INC.·Product code DTE·June 16, 2011

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015

    BD FocalPoint Slide Profiler and BD FocalPoint GS Review Station; Catalog Nos. 490398, 490653, 491085, 491086, 491090, 490189 The BD FocalPoint GS Imaging System is intended to assist in cervical cancer screening of BD SurePath Liquid-based Pap Test slides to detect evidence of squamous carcinoma, adenocarcinoma and their usual precursor conditions.

    FDA Enforcement
    Class III ·Terminated·Becton Dickinson & Co.·October 17, 2018