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

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    Auto 3D Bladder Volume Tool

    FDA 510(k)
    FDA Class 2 ·Radiology

    Pantheon System

    FDA UDI
    ADLER ORTHO SPA·08050880238187·Pantheon Shaft L140mm

    KNOWLES BANDAGE SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896056121·KNOWLES BANDAGE SCISSORS WITH GOLD SCREW ANGLED...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319742907·Ostrum Antrum Punch Forceps 7" (17.5cm), backw...

    INVADER FACTOR V

    FDA 510(k)
    FDA Class 2 ·Hematology

    DIMENSION TPSA CALIBRATOR, MODEL #RC459

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·May 27, 2024

    DREAMSTATION 2 ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·March 3, 2025

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·October 8, 2024

    DS2ADV AUTO CPAP

    FDA Adverse Event
    Injury ·RESPIRONICS, INC.·Product code BZD·July 30, 2024

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 2, 2013

    PROXIMATE*HCS HEMORR CIR STAPL

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 21, 2019

    LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM

    FDA Adverse Event
    Injury ·JOLIFE AB·Product code DRM·November 12, 2016

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAW·June 21, 2019

    2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM

    FDA Adverse Event
    Injury ·MAKO SURGICAL CORP.·Product code OLO·May 6, 2016

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016

    BIOMET StageOne Knee Femoral Cement Spacer Mold, 65 MM, Silicone, Sterile, Item 432165.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020