BEUDAMED
    17 results · 18ms · Sources: EU EUDAMED, US FDA

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    BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033070·Baltic Denture System BDLoad Sm7 PLSEbm6DFs D3 ...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319718100·Piffard Dermal Curette 6-1/4" (15.9cm), oval, s...

    Lingual Sheaths

    FDA UDI
    AMERICAN ORTHODONTICS CORPORATION·00190746146268·WELD LINGUAL SHEATH UL 036 W/LG HK DIST

    Citrelock ACL 7mm Femoral Reamer

    FDA UDI
    Acuitive Technologies, Inc.·00810027271310·

    ALPHATEC

    FDA Adverse Event
    ALPHATEC MFG INC. AKA NEXMED INC·Product code HWC·February 26, 2004

    MAMMOTOME EX

    FDA Adverse Event
    Malfunction ·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code KNW·June 7, 2006

    ETHIBOND EXCEL VALVE LOOP SUTURE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    JAMSHIDI BIOPSY NEEDLE

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

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·April 1, 2013

    ZENITH RENU AAA ANCILLARY GRAFT CONVERTER

    FDA Adverse Event
    Death ·COOK, INC.·Product code MIH·March 18, 2011

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 25, 2014

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 25, 2016

    NAIL, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code JDS·July 25, 2016

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024