BEUDAMED
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    MULTI-AXIAL CROSS (MAC) CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964009103·Endo Carry-On Procedure Kit

    Preat

    FDA UDI
    Preat Corporation·00842092182901·ASC NobelActive™/Conical-compatible RP Titanium...

    Epredia

    FDA UDI
    RICHARD-ALLAN SCIENTIFIC COMPANY·00673693214346·Cassettes are designed to contain incised tissu...

    Preat

    FDA UDI
    Preat Corporation·00842092183311·ASC NobelActive™/Conical-compatible RP – Milled...

    Synergy Disc Instruments

    FDA UDI
    Synergy Spine Solutions Inc·M67091000009650·Trial, Large, 5mm, 6°

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361008286·PedFuse ReTurn, Hex, CNL, 9.0mm x 65mm

    RESTORE

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·March 8, 2012

    NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CAMLOG CYLINDER IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    INSET

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·June 18, 2024

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 27, 2013

    COLLEAGUE COLOR PUMP CE FRENCHVERSION SINGLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·February 24, 2011

    LUMOS VR-T

    FDA Adverse Event
    Death ·BIOTRONIK GMBH AND CO.·Product code LWS·February 20, 2008

    Zimmer Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code IKX·July 7, 2008

    Zimmer Patient Helper Reinforce Overhead Bar for Hill-Rom Versa Care beds; Zimmer Inc., Warsaw, The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed. IN; Prod. Nos. 00-2700-965-02 and 00-0965-001-00.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code IKX·July 7, 2008

    Zimmer Freestanding Patient Helper for Hill-Rom Totalcare beds; Zimmer Inc., Warsaw, IN; Prod. Nos. 00-2700-965-00 and 00-0965-001-00. The product is a L shaped bar that is used with hospital beds set up for traction. The bar allows mounting of a trapeze to help the patient pull themselves up when in the hospital bed.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code IKX·July 7, 2008

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025