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

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    CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257009840·30-40 DUAL LAYER CALF SINGLE XL 10 PACK

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517096968·Armada Silicon Alum Rod Template, 250mm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776181918·BRUNS CURETTE ANG OVAL SIZE

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690117339·Modular Knee Stem Pilot 9mm x 150mm

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187295·Integra® Jarit® Bruns Oval Cup Curette, 8", Ang...

    IMMULISA ANTI-HUMAN TISSUE TRANSGLUTAMINASE (HU-TTG) ANTIBODY TOTAL IGA/IGG ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PRIME ZOOM STRETCHER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    QUATTRODE LEAD, 3/6MM, 30 CM

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·December 26, 2014

    I-STAT EG7+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024

    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·October 2, 2013

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 10, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011

    FINELINE I

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·July 22, 2013

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024

    Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number: FS252251502 Product Description: 5 French sheath, 0.014" guidewire compatible over-the-wire injectable angioplasty balloon catheter, balloon diameter 2.5mm, balloon length 225mm, catheter working length 150cm Component: NA

    FDA Enforcement
    Class II ·Ongoing·SUMMA THERAPEUTICS, LLC·April 8, 2026

    Stryker Vision Mounting Arm, for use with other Stryker Endoscopy medical device products for human patients. Model number 0240-095-200, manufactured by Stryker Endoscopy San Jose The intended use of the Stryker Vision Mount is to hold and position an LCD monitor. The Stryker Vision Mounting Arm can be used with any Stryker flat panel display and is It is compatible with Stryker Carts (0240099001, 0240099011 or 0240099020). It is indicated for use in a surgical operating room environment and is exposed to environmental conditions associated with the storage and shipping of the product. It is not intended to enter the sterile field. The Stryker Vision Mount does not deliver to and/or extract from the patient any energy or material. It does not process any biological materials, as it is not intended to be sterilized by the user. The Stryker Vision Mount is only used to display surgical images and video and does not sustain or support life.

    FDA Recall
    Terminated ·Stryker Endoscopy·Product code BZN·August 30, 2013