BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    PERI-STRIPS STAPLE LINE REINFORCEMENT - SLEEVE AND STRIP CONFIGURATIONS - AND PERI-STRIPS DRY STAPLE LINE REINFORCEMENT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Premier

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6911040415·CUBE PESSARY W/O DRAINAGE HOLES #5

    Expand 212® Helical Stone Basket

    FDA UDI
    C. R. Bard, Inc.·00801741076473·Expand 212® Helical Stone Basket

    Myo/Wire II

    FDA UDI
    A & E MEDICAL CORPORATION·10841291102236·SS Suture, 4 per sleeve

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193023278·B-P HIP FEMORAL STEM W/O HEAD, W/O BIOCOAT & W/...

    ISODAN

    FDA 510(k)
    FDA Class 2 ·Dental

    OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    TAPERED FINAL DRILL UNDERP.

    FDA UDI
    SWEDEN & MARTINA SPA·D7701349523·TAPERED FINAL DRILL UNDERP. SLEEVE 415 D.4.10 L...

    TAPERED FINAL DRILL

    FDA UDI
    SWEDEN & MARTINA SPA·D7701349493·TAPERED FINAL DRILL SLEEVE 415 D.4.10 L.4.00 MM

    INTERMEDIATE DRILL

    FDA UDI
    SWEDEN & MARTINA SPA·D7701348613·INTERMEDIATE DRILL SLEEVE 415 D.2.00 L.4.00 MM

    SATELLITE SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code NVR·May 5, 2011

    CARDIAC FUNCTIONAL ANALYSIS (CFA)

    FDA Adverse Event
    Malfunction ·VITAL IMAGES, INC.·Product code LLZ·March 12, 2013

    60" HIGH FLOW RATE EXTENSION SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·April 5, 2011

    JAGWIRE GUIDEWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·May 7, 2008

    PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024