BEUDAMED
    39 results · 21ms · Sources: EU EUDAMED, US FDA

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    NOVATION CROWN CUP GXL LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Bur PM2-70 50K Carb Ø3.5

    FDA UDI
    Bien-Air Surgery SA·07630055502452·

    Dark Star Deformity

    FDA UDI
    Republic Spine, LLC·B0751002690·Rod Rocker

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780432548·Integra® Jarit® Metzenbaum-Baby Dissecting Scis...

    COOLEY TANGENTIAL OCCL CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896002135·COOLEY TANGENTIAL OCCLUSION CLAMP ANGLED JAW AN...

    COOLEY TANGENTIAL OCCL CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921002690·COOLEY TANGENTIAL OCCLUSION CLAMP ANGLED JAW AN...

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 13, 2023

    BELLEGLASS HP OPACEOUS DENTIN

    FDA 510(k)
    FDA Class 2 ·Dental

    DURASPAN HEMODIALYSIS LONG-TERM CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD VACUTAINER K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·October 5, 2020

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·May 8, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·September 18, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 24, 2011

    AMISTEM-P STD STEM SIZE 8

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 4, 2024

    Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 12, 2015

    iCT, Model # 728306, computed tomography x-ray system

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 14, 2019

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Enforcement
    Class II ·Ongoing·Micro-X Ltd.·October 5, 2022

    The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·August 9, 2023

    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment supports, components and accessories

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·February 5, 2014

    HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, Product Number: 989710008732

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·June 12, 2024