BEUDAMED
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    PROLYTE ELECTROLYTE ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108692075·Hex Key Ø2.5mm, Short

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481110764·LOCATOR R-Tx Abutment for 4.2mm EV Internal Con...

    LOCATOR, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481131677·LOCATOR R-Tx Attachment System for Abutment EV ...

    LOCATOR F-Tx

    FDA UDI
    Zest Anchors, LLC·00840481115042·LOCATOR F-Tx Abutment for 4.2mm EV Internal Con...

    Paltop

    FDA UDI
    PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290108691511·Single-Unit Scan Abutment

    LOCATOR R-Tx, Dentsply Sirona System

    FDA UDI
    Zest Anchors, LLC·00840481137099·LOCATOR R-Tx Abutment EV (M) 4mm

    LOCATOR R-Tx

    FDA UDI
    Zest Anchors, LLC·00840481129179·LOCATOR R-Tx Abutment, 4.2mm Astra EV Connectio...

    PRIME ECG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CANDELA LONG PULSE ND:YAG

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

    Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

    FDA Enforcement
    Class I ·Terminated·WEST PHARMA. SERVICES IL, LTD·February 6, 2019

    POWER CORD, TGS SYSTEM V2, 20' LG

    FDA Adverse Event
    Malfunction ·MAKO SURGICAL CORP.·Product code OLO·October 8, 2019

    RSP SHOULDER

    FDA Adverse Event
    ENCORE MEDICAL, L.P.·Product code KWS·April 22, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 27, 2011

    SOFT TOUCH II

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·July 3, 2008

    Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only

    FDA Recall
    Terminated ·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018

    Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·November 9, 2016

    SPRINT QUATTRO SECURE MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVY·March 30, 2022

    LINER: CC E CC LIGHT FLAT PE LINER Ø 28 / F

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 4, 2017

    Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

    FDA Enforcement
    Class II ·Terminated·Paltop Advanced Dental Solutions Ltd·October 13, 2021