BEUDAMED
    27 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 ×

    PARCUS PEEK CF PUSH-IN SUTURE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REPICCI II RESURFACING KNEE SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304008137·

    Marienfeld Superior

    FDA UDI
    Paul Marienfeld GmbH & Co. KG·04250317329035·

    Corneal Trephine

    FDA UDI
    KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197116220·Thies Chisel 6 1/4"...

    MULTIPLE PRIVATE LABEL

    FDA 510(k)
    FDA Class 1 ·General Hospital

    STRYKER PLATING SYSTEM BASIC FRAGMENT SET

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 7, 2020

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 3, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 19, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 20, 2011

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·August 29, 2017

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·July 10, 2017

    STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System. Model P6500, 510 (k) Numbers: K090036 Cleared 4/05/2010; K101409 cleared 8/2/2010; K102462, cleared 9/2/2010; add to file 2/24/2011. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reuseable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.

    FDA Recall
    Terminated ·Steris Corporation Hopkins Facility·Product code MED·December 7, 2011

    Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology studies, for cardiac as well as interventional Radiology.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 9, 2020

    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

    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·November 6, 2024

    Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·November 24, 2021

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,

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