BEUDAMED
    21 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 ×

    LUXATEMP ULTRA /STAR

    FDA 510(k)
    FDA Class 2 ·Dental

    Aequalis™ Adjustable Reversed

    FDA UDI
    TORNIER, INC.·00846832068159·

    Hader

    FDA UDI
    Preat Corporation·20842092105317·Hader Metal Housing

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111371134·STERILIZ TRAY 10X6 1/2X2 1/2

    ELMED INCORPORATED

    FDA UDI
    ELMED INCORPORATED·00198506060618·Stainless Steel Hex Key, Tip Size 9/64 in, Long...

    NA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code MHY·December 23, 2022

    OXOID PBP2 1 LATEX AGGLUTINATION TEST

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ROLL-X GUIDEWIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SYNCHRON SYSTEMS DRUG CALIBRATOR 2

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code DLJ·April 26, 2012

    HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINER

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code KWZ·September 26, 2016

    0.8% SELECTOGEN FOR GEL

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·May 9, 2013

    BIODESIGN 4 LAYER TISSUE GRAFT

    FDA Adverse Event
    Injury ·COOK BIOTECH, INC.·Product code FTM·August 28, 2014

    DISCOVERY

    FDA Adverse Event
    Injury ·BIOMET·Product code LXH·May 23, 2011

    Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Generator ESG-410 Surgical Energy Platform (SEP). Model Number: WA91327U. The ESG-410 Electrosurgical Generator is an electrosurgical generator which utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments during open surgery, laparoscopic surgery, including single-site surgery, and endoscopic surgery.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·August 27, 2025

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

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

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    BleaseFocus Anesthesia Workstation and 700/900 Series Ventilators are anesthesia gas machine. In most cases, the customer ordered both a BleaseFocus anesthesia workstation and a 700/900 ventilator. In some cases, the customer may order a 700/900 stand-alone ventilator would could be used with a BleaseFocus anesthesia workstation at a later date.

    FDA Enforcement
    Class II ·Terminated·Del Mar Reynolds Medical, Ltd.·December 26, 2012