BEUDAMED
    14 results · 20ms · Sources: EU EUDAMED, US FDA

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    IntraOp VSP Software Device

    FDA 510(k)
    FDA Class 2 ·Radiology

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113929·GIANNETTI HYDRODISS CANNULA 26GA

    STILLE Chisels

    FDA UDI
    Stille AB·07332339206468·CHISEL ORIGINAL STILLE 8 mm 16.5 cm 6.5 in

    N LATEX LP(A)

    FDA 510(k)
    FDA Class 2 ·Immunology

    MICROAIRE SURGICAL INSTRUMENTS LLC

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

    VERSAFITCUP CC TERMINAL CUP IMPACTOR FOR METAL BACK CC

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code LXH·June 1, 2018

    TERMINAL CUP IMPACTOR FOR METAL BACK CC

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL, SA·Product code LXH·April 9, 2015

    0.8% SURGISCREEN FOR GEL

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·August 16, 2011

    CS300

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·August 4, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 9, 2013

    PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 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.·May 3, 2017

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021