BEUDAMED
    19 results · 24ms · 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 ×

    KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM

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

    MEDIPORT 2000 MOBILE

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

    FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYSTEM 98XT, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·February 3, 2026

    SYSTEM 98XT

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 22, 2025

    ASSY,ENGLISH,DOMSTC,110V,SYS98

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·December 26, 2025

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 3, 2025

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·November 18, 2025

    TENSION FREE VAGINAL TAPE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code OTN·April 17, 2013

    SEE H-10

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·April 19, 2011

    SILICONE ADVANCED OPTIC LENS

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·June 19, 2008

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·January 14, 2026

    Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

    FDA Recall
    Terminated ·Windstone Medical Packaging, Inc.·Product code FSY·April 22, 2015

    ASSY,ENGLISH,DOMSTC,110V,SYS98

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·September 15, 2025

    Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room

    FDA Enforcement
    Class II ·Terminated·Windstone Medical Packaging, Inc.·October 26, 2016

    SENSATION 7FR. 34CC IAB

    FDA Adverse Event
    Death ·DATASCOPE CORP. - FAIRFIELD·Product code DSP·February 2, 2021

    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.

    FDA Enforcement
    Class II ·Terminated·Biomet 3i, LLC·January 13, 2016

    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

    FDA Enforcement
    Class II ·Ongoing·CareFusion 303, Inc.·October 25, 2017

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015