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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    M-PM-DISC

    FDA 510(k)
    FDA Unclassified ·Unknown

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00885556600030·O*MTO SCR ENDO-FIX TAP 9MM DIA - SOD

    Trestle Luxe

    FDA UDI
    ALPHATEC SPINE, INC.·00844856067448·4.0mm Variable Angle, Self-Tapping Hexalobe Scr...

    Insignia

    FDA UDI
    ALPHATEC SPINE, INC.·00190376329611·4.0mm Fixed Angle, Self-Tapping Screw, Single L...

    Proximity

    FDA UDI
    ALPHATEC SPINE, INC.·00190376695075·PROXIMITY FA SELF-TAP SCREW, 4.0 x 15mm

    Segmental Plating System

    FDA UDI
    ALPHATEC SPINE, INC.·00190376545929·SPS FA Self-Tap Screw, 4.0 x 15 mm

    Complete Cervical

    FDA UDI
    Seaspine Orthopedics Corporation·10889981040956·Screw Self-Tapping - 4.0x15mm

    SHASER V-MINI HAIR REMOVAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EARLOOP PROCEDURE MASK

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ROCCIA

    FDA UDI
    Silony Medical GmbH·04054896032047·ROCCIA MultiLIF Cage 13x40 mm, 15° Lor.

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 29, 2013

    VOYAGER RX CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·June 20, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 2, 2014

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment supports, components, and accessories. Philips Inclusive CT has a 72cm bore and includes a detector array that provides 50cm scan field of view.

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·December 27, 2023

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015