BEUDAMED
    14 results · 20ms · 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 ×

    Interstitial Needles

    FDA 510(k)
    FDA Class 2 ·Radiology

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B5821608150·CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

    B-P TOTAL HIP SYSTEM

    FDA UDI
    ENDOTEC, INC.·00814193024701·B-P MODULAR EXTENSION W/ULTRACOAT - 15 MM X 200 MM

    JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    OXIBLUE FINGERTIP PULSE OXIMETER MODEL MD300C318, OXIPRO FINGERTIP PULSE OXIMETER MODEL MD300C316

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 29, 2023

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·October 10, 2014

    SAGITTAL SAW

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 30, 2011

    BD MULTI-CHECK CD4 LOW CONTROL

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code GKZ·August 16, 2023

    PRODIGY AUTOCODE

    FDA Adverse Event
    Injury ·OK BIOTECH CO., LTD.·Product code NBW·August 4, 2017

    Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

    FDA Enforcement
    Class II ·Ongoing·Guangzhou Improve Medical Instruments Co., Ltd.·May 1, 2019

    ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.

    FDA Enforcement
    Class II ·Terminated·Reshape Medical Inc·November 16, 2016

    Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025