BEUDAMED
    109 results · 21ms · Sources: EU EUDAMED, US FDA

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    Evita V800, Evita V600

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    16PW - Bleed Control - Poly White

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588620244·16PW - Bleed Control - Poly White

    SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (GREEN)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·May 24, 2024

    INTERSTIM X

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code EZW·September 19, 2025

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·November 6, 2008

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·August 17, 2011

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·July 3, 2013

    BD SYRINGE 10ML LL W/NDL 21GX1IN

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON DE MEXICO·Product code FMF·January 5, 2025

    regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·November 30, 2022

    MONARCH Bronchoscope. Model Number: MBR-000211-B

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·November 26, 2025

    MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)

    FDA Enforcement
    Class II ·Ongoing·Integra LifeSciences Corp.·October 16, 2024

    Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·February 7, 2024

    AQUABILITI AQUASTAT 0.9% Sodium Chloride Injection syringe, USP, 5mL in 12mL, REF 2T0805; and 3mL in 12mL, REF 2T0807, intermediate cartons containing 100 syringes, shipping cases containing 400 syringes, Rx, Sterile.

    FDA Enforcement
    Class II ·Ongoing·MRP, LLC dba Aquabiliti·February 28, 2024

    The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting Systems is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·July 17, 2024

    The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizing vessel branches. The harvesting tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization.

    FDA Enforcement
    Class II ·Ongoing·Maquet Cardiovascular, LLC·July 17, 2024

    Baxter Spectrum IQ Infusion Pump, Product Code 3570009

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·March 20, 2024

    ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    FDA Recall
    Open, Classified ·Onkos Surgical, Inc.·Product code KRO·September 22, 2024