BEUDAMED
    10 results · 27ms · 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.

    GENERAL PROCEDURE AGAROSE FILM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENDOCARE PERCUTANEOUS ACCESS SET

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

    DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3.5MM LOW PROFILE RECONSTRUCTION PLATE 4 HOLES

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HRS·January 24, 2020

    PROMETRA PROGRAMMABLE PUMP

    FDA Adverse Event
    Malfunction ·FLOWONIX MEDICAL INC.·Product code LKK·February 21, 2014

    IMPLANT PDS3000 6PK PILLAR PALATAL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MFG JACKSONVILLE·Product code LRK·October 19, 2012

    INNERVISION SNAP SHUNT VENT CATH, BIOGLIDE, 5CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·August 4, 2010

    Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or other applications requiring the removal of built up fluids. The suction canisters are used in operating rooms but are also used outside the surgical field as well as post-operatively within patient suites. The collection containers hold the fluids until they are ready for proper disposal. Sources of vacuum range from wall suction (central vacuum piped throughout the healthcare facility) to liposuction devices (portable suction pumps).

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 9, 2018

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

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