BEUDAMED
    1,218 results · 28ms · 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.
    Filters Regulation: Us FDA ×

    SafeGait Active Dynamic Mobility Trainer

    FDA UDI
    DIH TECHNOLOGY INC.·00860012112821·SafeGait Active S1000 system (Model SGAS1000) i...

    SafeGait 360 Balance and Mobility Trainer

    FDA UDI
    DIH TECHNOLOGY INC.·00860012112814·SafeGait 360 system (Model SG360) is a body wei...

    SafeGait Active 360 Dynamic Mobility Trainer

    FDA UDI
    DIH TECHNOLOGY INC.·00860012112838·SafeGait Active 360 system (Model SGA360) is de...

    Implant-One

    FDA UDI
    Implant Logistics, Inc.·D762DIH0310000·300 Series Implant Driver, Hand Piece Style

    Implant-One

    FDA UDI
    Implant Logistics, Inc.·D762DIH0510000·500 Series Implant Driver, Hand Piece Style

    Implant-One

    FDA UDI
    Implant Logistics, Inc.·D762DIH0410000·400 Series Implant Driver, Hand Piece Style

    SAFE GAIT ACTIVE 360 DYNAMIC MOBILITY TRAINER

    FDA Adverse Event
    Malfunction ·DIH TECHNOLOGIES INC.·Product code BXB·May 30, 2024

    Leica Biosystems Ariol Slide Exporter (SCN for DIH)

    FDA UDI
    Leica Biosystems Richmond, Inc.·00849832007814·Leica Biosystems Ariol Slide Exporter (SCN for ...

    DURAN ANCORE BAND

    FDA Adverse Event
    Injury ·HEART VALVES SANTA ANA·Product code KRH·June 16, 2018

    CHOLINESTERASE GEN.2

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code DIH·July 26, 2024

    MERGE UNITY PACS

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE·Product code LLZ·March 19, 2019

    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041; g) CONVENIENCE KIT, REF 60120336; h) LEFT HEART KIT, REF 60131446; i) 3 VALVE MANIFOLD OFF KIT WITH SQUEEZE CONTRAST CONTROLLER AND PROTECTION STATION, REF 60140798; j) CONVENIENCE KIT, REF 60142592; k) LEFT HEART KIT, REF 60183972; l) FOUR VALVE MANIFOLD KIT, REF 60210209; m) RIGHT HEART KIT, REF 60210862; n) LEFT HEART KIT, REF 600705710; o) CONVENIENCE KIT, REF 600803410; p) TUBING KIT; REF 601322913; q) LEFT HEART KIT, REF 60032582A

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·May 22, 2024

    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

    VITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800 4707 (90 slides);

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

    VITROS Chemistry Products CHE Slides packaged as 300 slides/pack catalog number 1914605 and packaged as 90 slides/pack catalog number 8004707 VITROS CHE Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DIH·June 12, 2013

    VITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides), (2) 684 4138 (300 slides);

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

    Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog Number: 806 7324 Software Version: Not Applicable Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems. VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added. Component: No, not a component

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DIH·June 10, 2025

    Colorimetry, Cholinesterase

    FDA classification
    FDA Class 1 ·Colorimetry, Cholinesterase

    Amvex Vacuum Regulator

    FDA UDI
    OHIO MEDICAL, LLC·00628101501044·VR-CI series, VacReg, Cont Int 300mmHg, Ohio A...

    DGH TECHNOLOGY, INC.

    FDA registration
    DGH TECHNOLOGY, INC.·2 products·🇺🇸 United States