BEUDAMED
    18 results · 21ms · Sources: EU EUDAMED, US FDA

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    SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065746·INTRAORAL ELASTICS 6,5 oz 1/4" red

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450238202·

    icotec Pedicle System 6.0, Rod, Ti, Curved, Ø 6.0 r120 x 070 mm

    FDA UDI
    icotec AG·07640164848693·icotec Pedicle System 6.0, Rod, Ti, Curved, Ø ...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0112070·Tap, Cannulated, 5.5 mm

    LASER PERIPHERALS REUSABLE HOLMIUM FIBER

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

    STARLIGHT

    FDA 510(k)
    FDA Class 2 ·Neurology

    NEOPUFF INFANT RESUSCITATOR

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·June 19, 2013

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 16, 2014

    MX-PRO R-3 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 20, 2011

    ADULT HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LIMITED·Product code BTT·December 16, 2010

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·September 22, 2010

    PINNACLE MTL INS NEUT36IDX50OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·October 22, 2013

    Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile, Box 1000 pouches 5 strips /pouch, Pouch , 5 strips 6 mm X100 mm Sterile EO Product Number: 40-2893: Wound Closure Strips , Sterile (1,000pouches/box) Rx; Pouch Label: Wound Closure Strips 6 mm X100 mm, 1/4" X 4 ", Rx Product Usage: intended for skin closure and closure support for sutures and staples

    FDA Enforcement
    Class II ·Terminated·Aspen Surgical Products, Inc.·August 28, 2013

    Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

    FDA Enforcement
    Class II ·Ongoing·Roche Diagnostics Operations, Inc.·January 6, 2021

    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

    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