BEUDAMED
    22 results · 29ms · Sources: EU EUDAMED, US FDA

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    AMMONIA-L3K ASSAY, MODEL 263-17, AMMONIA-L3K ASSAY, MODEL 263-30

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964011403·The ENDO CARRY-ON Procedure Kit contains all of...

    artVeneer life

    FDA UDI
    Merz Dental GmbH·D7092001285·artVeneer life lower anteriors, UCM, B4

    Vista

    FDA UDI
    Modus Medical Devices Inc·G34350012851·68 mm PET Jar & Black Lid - box of 64

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690123811·Tri Cut Tip- Tri-Drive pin

    OptiMesh Multiplanar Expandable Interbody Fusion System

    FDA UDI
    SPINEOLOGY INC.·M7401001285·4.75mm Rod Hand Brace

    MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INSET GUARD

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·March 30, 2026

    SEXTANT SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK·Product code MCV·October 29, 2009

    IMPAX CV REPORTING

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·February 24, 2011

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·February 22, 2008

    DATA-CYTE PLUS 2 0.8%

    FDA Adverse Event
    Malfunction ·MEDION GRIFOLS DIAGNOSTICS AG,·Product code QHT·September 11, 2024

    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code CAT·July 6, 2018

    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD Inc.·October 10, 2018

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

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

    PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx The LIFEPAK CR2 defibrillator is designed for indoor and outdoor use in a stationary environment. After the electrode pads are applied, the fully automatic model evaluates the heart rhythm and, if a shockable rhythm is detected, delivers a shock without any responder assistance. The LIFEPAK CR2 defibrillator is indicated for use on patients 1 year of age or older in cardiopulmonary arrest.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·March 17, 2021

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014