BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    ENDOCAM Flex HD Camera System 5521

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

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902757600·INSTRUMENT 8161204 2PRNG 4MM S STPL TRL

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772813841·GENUMEDI PRO SILVER SIZE IV

    Ceramco® II Silver™

    FDA UDI
    Dentsply International Inc.·D0011612040·

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694015875·Logic Jr Distraction Block

    VACUTRON

    FDA UDI
    Allied Medical, LLC·00026072009208·INTERMITTENT SUCTION REGULATORS

    MEG-2 BLOOD GLUCOSE MONITORING SYSTEM, MEG-2 50'S TEST STRIP, MEG-2 CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MASIMO SET RADICAL 7 PULSE CO-OXIMETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD BACTEC¿ MGIT¿ 960 SUPPLEMENT KIT

    FDA Adverse Event
    Malfunction ·LEE LABORATORIES, INC.·Product code MDB·July 6, 2023

    VANISHPOINT SYRINGE

    FDA Adverse Event
    Malfunction ·RETRACTABLE TECHNOLOGIES, INC.·Product code MEG·August 9, 2019

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·February 3, 2017

    LONG NAIL KIT R1.5, TI, RIGHT 10X340MM X 125

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·July 8, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·September 15, 2008

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·March 10, 2017

    Artis zeego, Model Number 10280959

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2020

    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·August 10, 2016

    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

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018