BEUDAMED
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    STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    VuePoint

    FDA UDI
    Nuvasive, Inc.·00887517174550·VuePoint Screw, 4.5x36mm Polyaxial Tulip

    Printed Upper ROC Pack for Herbst UL5

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015360·

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083011949·Fixed, 10 electrode, HIS, 2-5-2mm electrode spa...

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00673978079561·DISTRACTOR 901-536 SGL BARREL OS 18/10MM

    OPTIMA MR450W

    FDA 510(k)
    FDA Class 2 ·Radiology

    INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 2, 2020

    CUP: VERSAFITCUP CC ACETABULAR SHELL CC TRIO Ø 56

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 12, 2020

    STEM: AMISTEM-P COLLARED 01.18.436 AMISTEM-P COLLARED STD STEM SIZE 6

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·January 10, 2024

    OBTAPE TRANSOBTURATOR SLING

    FDA Adverse Event
    Injury ·MENTOR WORLDWIDE LLC·Product code OTN·June 18, 2014

    PRODISC-C REVISIONS

    FDA Adverse Event
    Injury ·SYNTHES·Product code MJO·January 8, 2013

    SPECTRA

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FAE·November 10, 2010

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025