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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    POWDER - FREE PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    MEDLINE INDUSTRIES, INC.

    FDA UDI
    MEDLINE INDUSTRIES, INC.·10198459467455·LACERATION TRAY 1

    Oticon

    FDA UDI
    Oticon A/S·05707131189776·K130, ITC P L BE

    Indus

    FDA UDI
    SPINEFRONTIER, INC.·00190361035725·Indus Invue MAX Symmetrical ACP, 4 Level, 65mm

    Tissue Punch

    FDA UDI
    BICON, LLC·00813110024480·6.5mm Tissue Punch

    ZAVATION TAP

    FDA UDI
    Zavation LLC·00197157013257·TIGER 2 TAP, Ø 6.5mm, EXCELSIUSGPS CANNULATED

    INFANT OXYGEN TREATMENT HOOD

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

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

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    24 G X 0.75 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    FDA Adverse Event
    Injury ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·August 11, 2017

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 29, 2025

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 30, 2013

    SHILEY

    FDA Adverse Event
    Injury ·COVIDIEN·Product code JOH·August 25, 2014

    RESERVOIR 1.8 ML

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·May 20, 2011

    ROD CUTTER

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXZ·January 31, 2022

    TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Enforcement
    Class II ·Terminated·American Optisurgical Inc·June 27, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Enforcement
    Class II ·Terminated·Optovue Inc.·October 31, 2012

    Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.

    FDA Recall
    Terminated ·Optovue Inc.·Product code OBO·September 7, 2012

    Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·January 22, 2014