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

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    SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Elite HD+ Putty Soft Normal Set

    FDA UDI
    ZHERMACK SPA·EZHIC2030021·Addition silicone impression material

    FLUID CONTROL

    FDA UDI
    Richard Wolf GmbH·04055207000366·ARTHRO IRRIGATION PUMP 150MMHG for arthroscopy...

    6PW - CPRotector® ONE Deluxe - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030012·6PW - CPRotector® ONE Deluxe - Poly White

    6PW - CPRotector® TWO Economy - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588030005·6PW - CPRotector® TWO Economy - Poly White

    Insurgical, Inc.

    FDA UDI
    Insurgical, Inc.·00850056900164·New VHP Reciprocating Saw

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·August 9, 2016

    STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CLEARFIL AP-X PLT

    FDA 510(k)
    FDA Class 2 ·Dental

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·October 17, 2008

    CAPSURE SP NOVUS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 11, 2011

    IMMULITE 2000 XPI

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS·Product code JJQ·July 2, 2013

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·November 13, 2014

    HANDPIECE MICS

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·July 9, 2019

    ROD, FIXATION, INTRAMEDULLARY

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HSB·July 25, 2016

    MAZOR X SYSTEM

    FDA Adverse Event
    Malfunction ·MAZOR ROBOTICS LTD·Product code OLO·January 1, 2026

    LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02

    FDA Recall
    Open, Classified ·Linkbio Corp.·Product code HSX·March 21, 2023

    LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02

    FDA Enforcement
    Class II ·Ongoing·Linkbio Corp.·May 10, 2023

    RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·September 10, 2025

    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No

    FDA Enforcement
    Class II ·Ongoing·RAYSEARCH LABORATORIES AB·January 28, 2026