BEUDAMED
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    SHERPA PAK CARDIAC TRANSPORT SYSTEM

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

    AGXO

    FDA UDI
    Oticon A/S·05707131262219·H110, RITE 312 WL SGR AGXO

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180176867·Biopsy Cup Forceps Serrated, Cystoscopy Flexib...

    Apricity

    FDA registration
    Apricity·2 products·🇺🇸 United States

    ELATION® MB

    FDA UDI
    DENTSPLY SIRONA ORTHODONTICS INC.·D807133432611·ELATION® MB Base Rx 022/LL3 -11T 7A HK

    K133532

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·February 2, 2021

    UNITY NETWORK ID

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEXATITE QUICK ACRYLIC

    FDA 510(k)
    FDA Class 2 ·Dental

    PHILIPS RESPIRONICS FACIAL CUSHION

    FDA Adverse Event
    Malfunction ·PHILIPS / RESPIRONICS, INC.·Product code BZD·April 8, 2026

    NELLCOR OXIMAX N-65

    FDA Adverse Event
    SANMINA-SCI SYSTEMS·Product code DQA·October 1, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·May 29, 2013

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·June 15, 2011

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MATRIX LOCKING CAP WITHOUT SADDLE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code NKB·February 16, 2015

    MATRIX LOCKING CAP WITHOUT SADDLE

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code NKB·February 16, 2015

    6.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH

    FDA Adverse Event
    Malfunction ·SYNTHES SELZACH·Product code NKB·February 16, 2015

    Philips Respironics DreamWear Full Face Mask

    FDA Enforcement
    Class I ·Ongoing·Philips Respironics, Inc.·October 12, 2022

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    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