BEUDAMED
    16 results · 20ms · Sources: EU EUDAMED, US FDA

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    Electric wheelchair (YHWL002, YHWL003)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Adler Instrument Company

    FDA UDI
    Adler, Inc.·00810123200603·GEMINI CLP 8-1/4

    Holder, Needle, TC, acc. Sarot 18cm

    FDA UDI
    Geister Medizintechnik GmbH·04057034065792·Holder, Needle, TC, acc. Sarot 18cm ...

    ORTHALIGN PLUS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·October 27, 2023

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    ZEPHYR XL DR

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011

    6MM FLUTED BALL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·July 17, 2013

    ARROW Endurance Extended Dwell Peripheral Catheter System

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 28, 2023

    NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·July 20, 2022

    NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·July 20, 2022

    STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.

    FDA Enforcement
    Class II ·Ongoing·Diagnostica Stago, Inc.·June 25, 2025

    DFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral Augmentation System, Reference/Catalog number 3427 - Product Usage: is intended for percutaneous delivery of StabiliT ER2 Bone Cement in kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·May 27, 2020

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·June 12, 2024

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025