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

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    BAYLIS PAIN MANAGEMENT GENERATOR MODEL: PMG-115 (FOR DOMESTIC USE), PMG-230 (FOR INTERNATIONAL USE)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019225·The ENDO CARRY-ON Procedure Kit contains all of...

    PedFuse®

    FDA UDI
    SPINEFRONTIER, INC.·00190361009283·PedFuse, Rod, Straight, Bulleted, 5.5mm X 65mm

    Coral

    FDA UDI
    Seaspine Orthopedics Corporation·10889981116903·6.5 Cannulated Tap

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·June 14, 2000

    STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO NC-STAT

    FDA 510(k)
    FDA Class 2 ·Neurology

    LUMA ARCH

    FDA Adverse Event
    Injury ·LUMALITE, INC.·Product code EEG·July 6, 2004

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 15, 2013

    K-WIRE CUTTING PLIERS (MAX 1.6MM)

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code LXH·January 28, 2011

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·February 8, 2008

    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    Medtronic Marinr Steerable, Product Number 72402; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code FYA·October 8, 2014

    Gown Surgical Poly Reinforced XL X-Long, Catalog number 900-2565. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·December 10, 2014

    bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD, Inc.·August 8, 2012

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: 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