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

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    MODIFICATION TO MAMMAPRINT

    FDA 510(k)
    FDA Class 2 ·Immunology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014609485·BERCHTOLD 3" STANDARD

    CANDELA SPTL-1E PULSED DYE LASER

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

    GENERIC BLOOD GLUCOSE TEST STRIP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITITE Container Kit, Full size, 4" high, product code: 13906. The ASP STERITITE sealed container system provides an efficient and cost-effective way to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation of contents.

    FDA Enforcement
    Class III ·Terminated·Advanced Sterilization Products·December 11, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 26, 2013

    GREENLIGHT ADDSTAT

    FDA Adverse Event
    Malfunction ·AMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·April 14, 2011

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    FDA Adverse Event
    Malfunction ·OBTECH MEDICAL SARL·Product code LTI·July 21, 2008

    CHROMID® CARBA SMART

    FDA Adverse Event
    Malfunction ·BIOMERIEUX S.A.·Product code JSO·August 23, 2018

    2.7MM UNIVERSAL DRILL GUIDE

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·October 8, 2019

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    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