BEUDAMED
    13 results · 22ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    QUIDEL CHLAMYDIA TEST

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Stern EX Acid Etched Implant RP 5.0x13.0mm, Direct Delivery, Ti

    FDA UDI
    STERNGOLD DENTAL LLC·00841549109003·The Sterngold Acid Etch Dental Implant System c...

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083012229·STR, 10 electrode, MPD-D, 5mm electrode spacing

    PATTERSON

    FDA UDI
    PATTERSON DENTAL SUPPLY, INC.·D6620709016600·PATTERSON C3 6-0 UPGA 18"/45CM

    Chisel

    FDA UDI
    BICON, LLC·00813110026118·6.0mm Curved Chisel

    CUSTOM COMFORT NIGHTGUARD VERSION 2

    FDA 510(k)
    FDA Unclassified ·Unknown

    MALLORY HEAD MODULAR CALCAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 30, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 17, 2010

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code DTB·January 2, 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

    The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. UniCel DxI 600 Catalog Numbers: A30260, A71460, A71461, A92060. Unicel DxI 800 Catalog Numbers: 973100, A71456, A71457, A84545, A25288, A25285.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter Inc.·April 10, 2019

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021