BEUDAMED
    19 results · 24ms · Sources: EU EUDAMED, US FDA

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    IBS Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    LACTOSORB® SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036063245·

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100301·INFANT WIRE SPECULUM 3MM/5MM BLADES

    TROUTMAN NEEDLE HOLDER

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896017818·TROUTMAN NEEDLE HOLDER WITHOUT LOCK EXTRA DELIC...

    Malibu

    FDA UDI
    Seaspine Orthopedics Corporation·10889981119911·PRECONTOURED ESS PLUS ROD, 5.5 x 350 MM

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776397791·Rubio Needle Holder, 7 3/4", serrated, TC, offs...

    AGC KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222083·

    BRIVO NM 615

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Neurology

    FREESTYLE PRECISION NEO H

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC.·Product code NBW·May 25, 2016

    DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE

    FDA Adverse Event
    Injury ·MPRI·Product code NVN·June 8, 2013

    VITALITY

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 7, 2011

    WALLFLEX ENTERAL COLONIC STENT

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·September 5, 2008

    AGC TRAD PRI TIB BEAR 10X71/75

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·November 20, 2018

    AGC MOD TIB II POR PLATE 75

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBH·November 19, 2018

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Comprehensive Reverse Shoulder System Humeral Tray Model 115340

    FDA Enforcement
    Class I ·Terminated·Zimmer Biomet, Inc.·February 22, 2017

    Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

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

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025