BEUDAMED
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    KIDNEY ASSIST-transport

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551136118·HALO, 1203-5 VEST X-LARGE, COOLMAX LINER, 1211-...

    ANTLIA III WOUND TREATMENT SYSTEM

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

    CERCON CERAM

    FDA 510(k)
    FDA Class 2 ·Dental

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAT·October 16, 2018

    ACCU-CHEK MOBILE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 15, 2011

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·October 22, 2008

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 8, 2013

    CustMbite, Model Number CBT-SRS-UL

    FDA Enforcement
    Class II ·Ongoing·Dental Choice Holding Llc·August 10, 2022

    OT SS ENHANCED METER

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code NBW·July 5, 2006

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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