BEUDAMED
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    MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR

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

    Dornier MedTech

    FDA UDI
    Dornier MedTech GmbH·04049957000028·Compact Sigma Lithotripter, 220V, 60 Hz

    Pointe Scientific, Inc.

    FDA UDI
    HORIBA INSTRUMENTS INCORPORATED·00811727013248·FSH for the quantitative determination of FSH c...

    SYNERGY HA COATED POROUS FEMORAL STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARBITURATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·July 1, 2024

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·March 19, 2026

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·January 25, 2012

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 3, 2024

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·April 29, 2025

    EVOKE CLOSED LOOP STIMULATOR (CLS) (US)

    FDA Adverse Event
    Injury ·SALUDA MEDICAL PTY LTD·Product code LGW·March 19, 2026

    ACCU-CHEK ® SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·May 9, 2013

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDI·September 19, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 25, 2011

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·April 14, 2022

    INTERGRATED APD SET

    FDA Adverse Event
    Malfunction ·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021