BEUDAMED
    32 results · 22ms · 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 ×

    MEDICON MOGEN CLAMP

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964061844·Endo Carry-on Procedure Kit includes Defendo 4-...

    Duette™

    FDA UDI
    POIESIS MEDICAL, LLC·20852732004047·16FR Duette™ Indwelling Urinary Catheter Tray

    Arena-L®

    FDA UDI
    SPINEFRONTIER, INC.·00190361005933·Arena-L, 35x26, Lordotic 8 degrees, 16H

    T2 SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code MQP·December 11, 2018

    Genius Tibial Trial Monobloc PS - 16mm

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215072438·

    Specials

    FDA UDI
    Seaspine Orthopedics Corporation·10889981321222·Shoreline Flex Drill, 16mm

    INSULIN SYRINGES ULTRA-FINE NEEDLE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·June 25, 2018

    AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PTW DOSIMETRY DIODE, T60008

    FDA 510(k)
    FDA Class 2 ·Radiology

    GYNECARE TVT-ABBREVO MINI LCM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·November 30, 2021

    CO-FLEX

    FDA Adverse Event
    Injury ·ANDOVER HEALTHCARE, INC.·Product code FRO·May 18, 2011

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 8, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·September 19, 2014

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

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

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021

    GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·April 11, 2018

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015