BEUDAMED
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    APTUS Hand System; APTUS Elbow Dorsal Olecranon

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180148895·D’ERRICO Hypophyseal Forceps Bayonet Shaped, St...

    Marcolin U.S.A. Eyewear Corp.

    FDA registration
    Marcolin U.S.A. Eyewear Corp.·3 products·🇺🇸 United States

    ABSORBENT PAPER POINTS

    FDA UDI
    DiaDent Group International·08806383516273·"An absorbent paper points is an endodontic pap...

    Automatic Anatomy Recognition (AAR)

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD INTIMA II CLOSED IV CATHETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

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    FDA Adverse Event
    Malfunction ·OMNICELL, INC.·Product code LNX·November 7, 2008

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·July 27, 2011

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS, INC·Product code LZG·July 23, 2013

    ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek¿ lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek¿ lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·December 27, 2017

    INTIMA II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·October 31, 2018

    ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The bagged component will then be placed in an inner PETG tray. The screw will be placed inside a separate polybag, and placed in the PETG tray with foam pieces added to the top and bottom of the tray for protection. The inner tray and the contents within will then have a Tyvek lid heat sealed to the tray. The sealed inner tray will be fit into an outer PETG tray and a Tyvek lid heat sealed to the tray. The entire sealed unit is placed in a SBS carton that will be shrink wrapped for protection.

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code KWI·June 16, 2017

    Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222, 722223, 722224, 722225, 722226, 722227, 722228) running StentBoost Live (Model Number 459801781661) Software Version Number: R2.0

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·April 13, 2022

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024