BEUDAMED
    18 results · 24ms · Sources: EU EUDAMED, US FDA

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    SIGNATURE PLANNER / SIGNATURE GUIDES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180168923·Dressing forceps, Serrated. Overall length 6in ...

    PROFYLE

    FDA UDI
    Stryker GmbH·07613154126781·Drill, WL 16mm, Dental-Shaft

    TMA - Archwire

    FDA UDI
    ORMCO CORPORATION·00889989028294·TMA BROAD ARCH LO LGE 0210 0250 PK/10

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158218222·FORCEPS USA DRESSING STRAIGHT 6"

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1104250·Tray, Base, 4.25", Arcamed

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1104250·Tray, 4.25 Inch Base

    ISODAN

    FDA 510(k)
    FDA Class 2 ·Dental

    ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 21, 2025

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 13, 2013

    SYMBIQ SCHANNEL 3.01

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·September 16, 2014

    M1 AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code INK·April 25, 2011

    NI

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DTI·June 11, 2021

    SIZER, HEART-VALVE, PROSTHESIS

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DTI·June 11, 2021

    Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

    FDA Enforcement
    Class II ·Terminated·Pentax of America Inc·August 30, 2017

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    EVIS EXERA II Gastrovideoscope OLYMPUS GF type UCT180; designed for endoscopic real-time ultrasound imaging, ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·October 7, 2015