BEUDAMED
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    LINK TO ACUITY CLINICIAN NOTIFIER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ID Adapter

    FDA UDI
    WEST PHARMA. SERVICES IL, . LTD·07290108240900·Intradermal Adapter

    LOCATOR, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481131738·LOCATOR R-Tx Attachment System for Abutment EV ...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481115097·LOCATOR F-Tx Abutment for 4.8mm EV Internal Con...

    LOCATOR R-Tx, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481137150·LOCATOR R-Tx Abutment EV (L) 4mm

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110825·LOCATOR R-Tx Abutment for 4.2mm EV Internal Con...

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108693997·Step Drill Stop for L11.5mm Implant, Narrow Long

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129230·LOCATOR R-Tx Abutment, 4.8mm Astra EV Connectio...

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 27, 2022

    STRYKER NAVIGATION SYSTEM-KNEE MODULE

    FDA 510(k)
    FDA Class 2 ·Neurology

    WIN-1 TANGO

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·March 3, 2025

    THE CLOSER AK

    FDA Adverse Event
    Injury ·PERCLOSE, INC.·Product code MGB·August 18, 2004

    ILAB? POLARIS MULTI-MODALITY GUIDANCE SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQK·May 14, 2026

    CORAIL2 NON COL HO SIZE 11

    FDA Adverse Event
    Injury ·DEPUY FRANCE SAS - 3003895575·Product code KWA·April 22, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 8, 2014

    PRECISION XTRA/OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·July 3, 2008

    Ross Hide-A-Port Low Profile Balloon Gastrostomy Tube Kit, 24 Fr., 4.0 cm length, Item Number: 55723.

    FDA Recall
    Terminated ·Ross Products Division Abbott Laboratories·Product code KNT·March 1, 2004

    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the 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. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013

    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