90 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code MHX·March 13, 2017
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·July 9, 2014
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
FDA Enforcement
Class II
·Terminated·Nihon Kohden America Inc·April 19, 2017
CNS-6200 Series Central Nurse Station and accessories. Model Number: CNS-6201 For cardiac and vital signs monitoring for multiple patients.
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code MHX·June 3, 2014
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