BEUDAMED
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    ACE ALT REAGENT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750001316·7600 SM FF W/AAV 22ID QREL HDG

    Brainlab Interface Rotating, with Marking

    FDA UDI
    Noras MRI products GmbH·04251269204715·

    INTERCONTINENTAL PLATE-SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO: STACKABLE CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TINBN COATED

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 28, 2023

    GMK PRIMARY FEMUR SIZE 4 LEFT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 31, 2012

    PROG VALVE INLINE

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·June 14, 2022

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP·Product code LLZ·February 28, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·May 15, 2013

    SMITH'S CADD CASSETTE

    FDA Adverse Event
    Injury ·SMITH'S MEDICAL·Product code FPA·May 26, 2011

    PROG VALVE INLINE

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·September 1, 2021

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021