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

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    ZOE FLUID STATUS MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089476770·

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089476619·

    D-Fine Double Diamond™ Primary Polisher Refill #09

    FDA UDI
    CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172001861·Dental burnisher

    GYRUS ACMI, INC

    FDA UDI
    Gyrus ACMI, LLC·00821925018938·REUSABLE BIPOLAR CORD LENGTH 12.0'

    Kirwan (Distributor Gyrus ACMI)

    FDA UDI
    KIRWAN SURGICAL PRODUCTS LLC·00841019108802·Bipolar Cord TPR Reusable, Length: 12 ft.

    HAcancellous™ PEEK-C

    FDA UDI
    INNO Holdings, Inc.·M711591315090·HAcancellous PEEK-C, 13L x 15W x 9H x 8°, HA PE...

    Cadet Cervical Cage

    FDA UDI
    VALORUS SPINE LLC·00811771033964·Cadet Cervical Cage, 13mm x 15mm x 09mm, 7° Lor...

    K2M General Instruments

    FDA UDI
    VB Spine LLC·10888857561106·Parallel Trial Size 9x28x14 mm

    Cadet Cervical Cage

    FDA UDI
    VALORUS SPINE LLC·00811771033339·Cadet Cervical Cage, 13mm x 15mm x 09mm, Non-Lo...

    U-RIGHT TD-4279 BLOOD GLUCOSE MONITORING SYSTEM, FORA GD40/TD-4272 BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SWEETSPOT DIABETES DATA MANAGEMENT SERVICE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·October 1, 2014

    V12 COVERED STENT

    FDA Adverse Event
    Malfunction ·ATRIUM MEDICAL CORP.·Product code JCT·May 14, 2013

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

    FDA Adverse Event
    Malfunction ·ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.·Product code FPA·June 13, 2025

    Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.

    FDA Enforcement
    Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025

    E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Sterile. RX ONLY. This product is packaged individually in a chevron Tyvek¿ - polyester peel pouch, 6 pouches per box. The E-Z Clean laparoscopic electrode is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during laparoscopic surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated.

    FDA Enforcement
    Class II ·Terminated·Megadyne Medical Products, Inc.·September 4, 2013

    Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone

    FDA Enforcement
    Class II ·Terminated·Amendia, Inc·December 28, 2016