BEUDAMED
    19 results · 28ms · Sources: EU EUDAMED, US FDA

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    CONFIRM ANTI-PROGESTORONE RECEPTOR (1E2) RABBIT MONOCLONAL PRIMARY ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Hematology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772814725·GENUMEDI EXTRA WIDE SAND SIZE IV

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964078248·The ENDO CARRY-ON Procedure Kit contains all of...

    EXTREME MICRO MOSQUITO FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896053618·EXTREME MICRO MOSQUITO FORCEPS EXTREMELY DELICA...

    GEN4 INTERACTIVE

    FDA UDI
    CURBELL MEDICAL PRODUCTS, INC.·00840828160810·GEN4 INTERACTIVE

    Paragon 28

    FDA UDI
    Provision·B504OMP9911038180·

    Monster® Screw System

    FDA UDI
    Paragon 28, Inc.·00889795052001·Drill, 3.8mm x 180mm, Cannulated, AO

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857520387·Split Tube Retractor, Size Ø14x100 mm

    AUTOGENESIS AUTOMATOR, MODEL M1000

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TITANIUM ABUTMENT HEADS FOR IMZ IMPLANTS

    FDA 510(k)
    FDA Class 2 ·Dental

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 3, 2024

    AGX

    FDA UDI
    Widex A/S·05706069748260·Audigy AGXWU-FM (Summer gold S-220 ) RC coil

    AGX

    FDA UDI
    Widex A/S·05706069749113·Audigy AGXWU-FP (Summer gold S-220 ) Telecoil, ...

    CAPITAL BLOOD/FLUID WARMER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code KZL·September 25, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021