BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    COMPACT PIEZO LED

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517728074·CoRoent Large MP, 10x9x23mm 15°

    HHM

    FDA UDI
    Oticon A/S·05707131282835·H110V2, BTE 13 WL 100 TC HHM

    AGC Tradition Knee System

    FDA UDI
    Biomet Orthopedics, LLC·00880304240506·

    N/A

    FDA UDI
    Smith & Nephew, Inc.·00817470009026·45 DEG. PICK

    ABBOTT ARCHITECT LH CALIBRATORS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    TOPEZ TOTAL ANKLE REPLACEMENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U-BLADE SET, TI GAMMA3 10.5X90MM

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS KIEL·Product code HSB·November 30, 2012

    PENUMBRA SYSTEM MAX ASPIRATION TUBING

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code NRY·June 24, 2015

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·June 6, 2013

    CORE MICRO DRILL

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·October 8, 2014

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC. USA·Product code NBW·August 29, 2008

    MOZEC¿ NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·April 28, 2023

    MOZECTM NC RX PTCA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·MERIL LIFE SCIENCES PRIVATE LIMITED·Product code LOX·October 21, 2023

    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.

    FDA Recall
    Terminated ·Acrymed Incorporated·Product code FRO·June 30, 2008

    SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 26, 2014

    Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·April 9, 2014

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNCUFFED , Product Code/List Number/Item Code 60P030; c) PAED. TRACHEOSTOMY TUBE 3.5MM UNCUFFED , Product Code/List Number/Item Code 60P035; d) PAED. TRACHEOSTOMY TUBE 4.0MM UNCUFFED , Product Code/List Number/Item Code 60P040; e) PAED. TRACHEOSTOMY TUBE 4.5MM UNCUFFED , Product Code/List Number/Item Code 60P045; f) PAED. TRACHEOSTOMY TUBE 5.0MM UNCUFFED , Product Code/List Number/Item Code 60P050; g) PAED. TRACHEOSTOMY TUBE 5.5MM UNCUFFED , Product Code/List Number/Item Code 60P055

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