BEUDAMED
    18 results · 34ms · Sources: EU EUDAMED, US FDA

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    ENZYMUN TEST(R) INSULIN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    NA

    FDA UDI
    Smith & Nephew, Inc.·00885554007817·SOD DRILL 9MM WITH 3.2MM CANNULATION

    GRADIA®

    FDA UDI
    Gc America Inc.·D0479011351·GRADIA PLUS DTip LP Cover 5pc

    Burnshield

    FDA UDI
    BURNSHIELD (PTY) LTD·06007645003957·BURNSHIELD 60X40CM FACEMASK

    Map-iT

    FDA UDI
    ACCESS POINT TECHNOLOGIES, INC.·00818083011635·Fixed, 6 electrode, HIS, 2-5-2mm electrode spacing

    6F & 7F INTRODUCING CATHETERS (MODIFICATION)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RUTTER SUPRA STOMAL STENTS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981141264·Solid Tap Tri-Flat, Dia 3.50mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981141257·Solid Tap Tip, Dia 3.50mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981141233·Solid Tap, Dia 3.50mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981141271·Solid Tap Short, Dia 3.50mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981141288·Solid Tap Long, Dia 3.50mm

    Mariner

    FDA UDI
    Seaspine Orthopedics Corporation·10889981141240·Solid Tap A/O, Dia 3.50mm

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 30, 2014

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 8, 2013

    #7 SCORPIO 4:1 CERAMIC BLOCKS

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS MAHWAH·Product code LXH·November 10, 2010

    Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014

    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