BEUDAMED
    23 results · 20ms · 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.

    Smart Check O2 (MA0236)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ICU Medical

    FDA UDI
    ICU MEDICAL, INC.·00840619040857·Transpac™ IV MONITORING KIT WITH 2 BONDED STOPC...

    Ormco

    FDA UDI
    ORMCO CORPORATION·00889989031331·QUICK NANCE - SIZE 2 - PK OF 10

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481125928·LOCATOR R-Tx Attachment System, 3.5/4.1 IC Impl...

    Kleiner KG2 system

    FDA UDI
    Baat Medical Products B.V.·08720246782738·T-handle, Hudson Connect

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·Quest Diagnostics AAVrh74 Antibody ELISA CDx

    Monkey Rings™ External Fixation System

    FDA UDI
    Paragon 28, Inc.·00889795116307·Rancho Cube, 2 hole

    iNSIGHT Color Doppler Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITEK 2 COMPACT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    COLLEAGUE CX TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·January 12, 2010

    TRANSPAC IV MONITORING KIT

    FDA Adverse Event
    Other ·ICU MEDICAL, INC.·Product code FPA·December 22, 2011

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·November 22, 2024

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 22, 2008

    SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·September 16, 2024

    PFNA BLADE PERF L110 TAN

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code HSB·November 14, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·September 15, 2011

    LAP-BAND AP ADJUSTABLE GASTRIC BANDING SYSTEM (STANDARD)

    FDA Adverse Event
    Injury ·ALLERGAN·Product code LTI·July 24, 2013

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·December 2, 2024

    Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·December 17, 2025

    TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42500-02 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.

    FDA Enforcement
    Class II ·Terminated·ICU Medical, Inc.·November 23, 2016