BEUDAMED
    120 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 ×

    AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Vascular Probe

    FDA UDI
    SYNOVIS LIFE TECHNOLOGIES, INC.·00085412532578·The Vascular Probe is a sterile, single use, di...

    XENMATRIX

    FDA UDI
    Davol Inc.·00801741074288·XenMatrix AB Surgical Graft, 20 cm x 25 cm

    LACTOSORB® 2.0MM SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036054021·

    TALOS° HA PEEK IBF

    FDA UDI
    MEDITECH SPINE, LLC·B167321520250·

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·April 24, 2024

    COMBAT READY CLAMP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    URGENT PC NEUROMODULATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specialty Brochure US version which affect: Vascular Probe, Item Numbers: a) 7081015, b) 7081015ES, c) 7081520, d) 7081520ES, e) 7082025, f) 7082025ES, g) 7151015, h) 7151015ES, i) 7151520, j) 7151520ES, k) 7152025, l) 7152025ES, m) 7451015, n) 7451015ES, o) 7451520, p) 7451520ES, q) 7452025, r) 7452025ES

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code DXC·February 22, 2024

    HAMILTON-G5

    FDA Adverse Event
    Malfunction ·HAMILTON MEDICAL AG·Product code CBK·December 10, 2025

    INTERSTIM II

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·October 8, 2014

    ENRHYTHM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NVZ·June 7, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·July 7, 2011

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 6, 2025

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    TR BAND

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DXC·May 26, 2023

    MONARCH Bronchoscope. Model Number: MBR-000211-B

    FDA Enforcement
    Class II ·Ongoing·Auris Health, Inc·November 26, 2025

    Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c) 7082025: 8CM, 2-2.5 MM GLOBAL, d) 7151015: 15CM, 1-1.5 MM GLOBAL, e) 7151520: 15CM, 1.5- 2 MM GLOBAL, f) 7152025: 15CM, 2- 2.5 MM GLOBAL, g) 7451015: 45CM, 1- 1.5 MM GLOBAL, h) 7451520: 45CM, 1.5- 2 MM GLOBAL, i) 7452025: 45CM, 2- 2.5 MM GLOBAL, j) 7081015ES: 8CM, 1-1.5 MM GLOBAL, k) 7081520ES: 8CM, 1.5- 2 MM GLOBAL, l) 7082025ES: 8CM, 2-2.5 MM GLOBAL, m) 7151015ES: 15CM, 1-1.5 MM GLOBAL, n) 7151520ES: 15CM, 1.5- 2 MM GLOBAL, o) 7152025ES: 15CM, 2-2.5 MM GLOBAL, p) 7451015ES: 45CM, 1-1.5 MM GLOBAL, q) 7451520ES: 45CM, 1.5-2 MM GLOBAL, r) 7452025ES: 45CM, 2-2.5 MM GLOBAL

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 17, 2024

    Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay, REF: PRD-07400

    FDA Enforcement
    Class II ·Ongoing·Hologic, Inc.·January 1, 2025

    Arthroscopy Pack, MSKA45A; Medical convenience kit

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·October 2, 2024