BEUDAMED
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    POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Fixed Reference Posterior ROT Guide 0 deg

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215056391·

    SYMPHONY

    FDA UDI
    Medos International Sàrl·10705034527635·SYMPHONY OCT SYSTEM DUAL DIAMETER ROD COBALT CH...

    SPIRA®-A Integrated

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030SAZ1020960·SPIRA®-A Integrated,Trial, 28x32mm, 8° Lordotic...

    SYMPHONY

    FDA UDI
    Medos International Sàrl·10705034527628·SYMPHONY OCT SYSTEM DUAL DIAMETER ROD COBALT CH...

    COVERIS

    FDA UDI
    CAMBER SPINE TECHNOLOGIES, LLC·B030CS1020960·Trial, 13 x 18mm, 3° Lordotic, 12mm

    DISPOSABLE VITRECTOMY LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 1, 2024

    INFUSE BONE GRAFT 12 MG

    FDA Adverse Event
    Injury ·MEDTRONIC·Product code NEK·May 1, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·April 23, 2013

    DEXTUS 4135

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVN·September 19, 2014

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·April 20, 2011

    MICRUSPHERE XL 6MMX20CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·November 20, 2020

    ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)

    FDA Enforcement
    Class II ·Ongoing·Healthmark Industries Co., Inc.·June 11, 2025

    AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil.

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec AG·December 9, 2015

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025