BEUDAMED
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    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 7, 2021

    Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. (CHINA only) SureSigns VM4 (863063, 863085) SureSigns VM6 (863064, 863065, 863086) SureSi"gns VM8 (863066, 863068, 863087, 863088) Model Numbers: 863063,863064,863065,863066,863068,863085,863086, 453564021961,453564021971, 53564022001,453564022041, 53564022081,453564024371, 453564024401,453564024421 453564024441,453564024461, 453564024481

    FDA Recall
    Terminated ·Philips North America, LLC·Product code MHX·March 23, 2021

    ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting shaping bone including spine and cranium.

    FDA Enforcement
    Class II ·Terminated·The Anspach Effort, Inc.·August 5, 2015

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Recall
    Terminated ·Galt Medical Corporation·Product code DYB·May 2, 2018

    Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel: (800) 327 6887 / + 1 561 627 1080***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe, HP 11 1LA***United Kingdom***Tel: +441494 616126***Rx Only***LOT C323023789***. Cutting and Shaping bone including bones of the spine and cranium.

    FDA Recall
    Terminated ·The Anspach Effort, Inc.·Product code HBC·May 9, 2011

    Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N

    FDA Recall
    Terminated ·Cardinal Health·Product code FYA·January 11, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020

    AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC

    FDA Enforcement
    Class II ·Terminated·Cardinal Health·February 12, 2020