BEUDAMED
    17 results · 35ms · Sources: EU EUDAMED, US FDA

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    WILSON-COOK RETRIEVAL & GRASPING FORCEPS

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

    Synergy

    FDA UDI
    Rmo, Inc.·00885797101006·ROTH SY 022 W/O HK 5-5 20EA

    4.5mm BONE-LOK PLS Implant

    FDA UDI
    INTERVENTIONAL SPINE, INC·81195401002786·4.5mm O.D. x 30-40mm Length

    2.5 x 34CM LIGHTWEIGHT GALILEAN LOUPE - 902400

    Device
    EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

    ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5

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

    MODIFICATION OF ACL ADVANCE

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEARTSTART ELECTRODE CABLE

    FDA Adverse Event
    Death ·LAERDAL MEDICAL, A.S.·Product code LDD·June 14, 2005

    CODEMASTER 100 PORTABLE DEFIBRILLATOR

    FDA Adverse Event
    Death ·HEWLETT-PACKARD CO.·Product code LDD·March 10, 1999

    COMPRESSION TOOL

    FDA Adverse Event
    Malfunction ·INTERVENTIONAL SPINE, INC.·Product code HWN·February 28, 2011

    SCREW

    FDA Adverse Event
    Malfunction ·INTERVENTIONAL SPINE, INC.·Product code MRW·February 28, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 8, 2013

    OT ULTRA EASY

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 18, 2010

    Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.

    FDA Recall
    Terminated ·Interventional Spine Inc·Product code MRW·March 15, 2011

    ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples.

    FDA Enforcement
    Class II ·Terminated·Beckman Coulter Inc.·November 13, 2013

    UniCel DxI 600 Access Immunoassay Analyzer, Part Number A30260

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025