BEUDAMED
    34 results · 29ms · 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 FDA Enforcement ×

    Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

    FDA Enforcement
    Class II ·Terminated·ORIGIO, Inc·July 9, 2014

    Brand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY Model/Catalog Number: 555076 Software Version: N/A Product Description: CESK NORTHSIDE ANESTHESIA TRAY Component: No

    FDA Enforcement
    Class II ·Ongoing·B Braun Medical Inc·June 10, 2026

    The ZYTO Select and ZYTO Elite software programs are used to rank pairs of galvanic skin response measurements from most coherent (the second scan is closest in time measurement to the baseline original scan) to least coherent (further away from the baseline).

    FDA Enforcement
    Class II ·Terminated·ZYTO Technologies, Inc.·July 13, 2016

    Original M.E. Mueller" Low Profile Cup Sterile, Rx

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·November 14, 2012

    USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700. Brochure: "EXER-REST***A patented, FDA registered, Acceleration Therapeutics device delivering Whole Body Periodic Acceleration to the user for symptomatic relief of a wide range of complaints***Whole Body Periodic Acceleration (WBPA)***WBPA is accomplished utilizing the Ever-Rest device to move the body repetitively head to foot at approximately 140 times a minute. This repetitive motion adds pulses to your natural vascular pulse with each acceleration and deceleration of the body. These additional pulses act on the inner lining of blood vessels (endothelium) throughout the body, a process called pulsatile shear stress, to promote the release of beneficial substances (mediators). These mediators, such as nitric oxide, provide a wide range of health benefits that originate from the user's own body.***Nitric Oxide (NO) is released from endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow throughout the circulation.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***[email protected] www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***USA-002 Rev A***" Printed marketing brochure

    FDA Enforcement
    Class II ·Terminated·Non-Invasive Monitoring Systems, Inc.·June 27, 2012

    OMTMO One Step Ovulation (LH) Test Strips REF 200-07

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio Pregnancy Strips REF 100-4 25 HCG Test Strips

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Lem Fertility LH Ovulation Test (Strip) REF 200-07

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150 test strips

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    Lem Fertility hCG Pregnancy Urine Test REF 100-12

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    DiagnosUS Pregnancy Test Midstream REF 100-17

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    One Step Pregnancy Test REF 100-01

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    One Step Ovulation Test REF 200-01

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio BREAST MILK ALCOHOL TEST STRIP REF 910-10 25 TESTS

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    To Life hCG Pregnancy Urine Test Strips Format REF Cat No: 100-10

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023

    PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10

    FDA Enforcement
    Class II ·Ongoing·Universal Meditech Inc.·November 1, 2023