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

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    TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter

    FDA Enforcement
    Class I ·Ongoing·GE Healthcare Finland Oy·July 12, 2023

    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

    HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769

    FDA Enforcement
    Class II ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·August 31, 2022

    The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.

    FDA Enforcement
    Class II ·Terminated·Synvasive Technology Inc·April 24, 2013

    a. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS), Catalog #3563. b. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AG2X2" (10/BX 10BX/CS) Catalog #3557. c. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X4.75" (10/BX) Catalog #3558. d. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGSHEET 4"X8" (5/BX 10 Catalog #3559. e. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE AGROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3560. f. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 2"X2" (10/BX 10BX/C Catalog #3561. g. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X4.75" (10/BX 1 Catalog #3562. h. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE SHEET 4"X8" (5/BX 10BX/CS) Catalog #3563. i. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, CALCIUM ALGINATE ROPE 3/4"X12" (5/BX 10BX/CS) Catalog #3564. j. ADVANCED MEDICAL SOLUTIONS McKesson DRESSING, SKIN FOLD MGMNT AG 10"X144" (1/BX 12BX/CS) Catalog #16-10144R

    FDA Enforcement
    Class III ·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·October 5, 2022

    Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·July 5, 2017

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025

    Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

    FDA Enforcement
    Class II ·Ongoing·Dentsply IH, Inc.·September 3, 2025

    Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model. Component: not a component

    FDA Enforcement
    Class II ·Ongoing·Dentsply IH, Inc.·September 3, 2025

    LoFric Origo, Nelaton, 16in, FR10 urinary catheters

    FDA Enforcement
    Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020

    LoFric Origo, Tiemann, 16in, FR12 urinary catheters

    FDA Enforcement
    Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020

    LoFric Origo, Tiemann, 16in, FR14 urinary catheters

    FDA Enforcement
    Class II ·Terminated·Wellspect HealthCare (Division of DENTSPLY IH AB)·July 29, 2020