BEUDAMED
    17 results · 23ms · 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 ×

    FLOW-NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Tube set for suction, single-use

    FDA UDI
    W.O.M. World of Medicine GmbH·04056702000783·

    PRINCETON

    FDA UDI
    Princeton Medical Group, Inc.·00810158218307·RETRACTOR CLOWARD FOR CERVICAL TISSUE 19MM 5"

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481120916·LOCATOR R-Tx Abutment For UF(II) Regular/Wide I...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319740811·Foerster Sponge (Ring) Forceps 12" (30.5cm), se...

    UNIVERSAL 320 R

    FDA UDI
    Andreas Hettich GmbH·04050674038263·refrigerated bench-top centrifuge without rotor

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197056021·PRESBYTERIAN Tubing Clamp, smooth smooth...

    REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

    FDA Adverse Event
    Injury ·SHASER INC·Product code ONF·May 21, 2021

    EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SENTINELLA 102

    FDA 510(k)
    FDA Class 1 ·Radiology

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·January 5, 2015

    MICROFRANCE® INSTRUMENT

    FDA Adverse Event
    Malfunction ·XOMED MICROFRANCE MFG·Product code GEI·November 25, 2014

    VISCOELASTIC CANNULA

    FDA Adverse Event
    Injury ·HURRICANE MEDICAL·Product code HMX·July 23, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 31, 2013

    ACCU-CHEK AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·August 28, 2008

    LIGASURE IMPACT THORACIC

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·June 16, 2011

    Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system

    FDA Enforcement
    Class II ·Ongoing·Intuitive Surgical, Inc.·June 10, 2026