25 results
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7ms
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Sources: EU EUDAMED, US FDA
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
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 Enforcement
Class II
·Terminated·Galt Medical Corporation·August 8, 2018
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
AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
FDA Enforcement
Class II
·Terminated·Cardinal Health·February 12, 2020
30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system.
FDA Enforcement
Class II
·Ongoing·B. Braun Medical, Inc.·November 15, 2023
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage: The connecting tube is intended to be a conduit between a fluid reservoir and a vascular catheter in the patient. The connecting tube may be used during angiographic procedures to connect radiographic contrast power injector to a vascular catheter, arterial pressure monitoring, and fluid infusion.
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 16, 2018
SQ40S Blood Transfusion Filter
FDA Enforcement
Class II
·Ongoing·GVS TM, Inc·January 28, 2026
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
On Site Gas Systems POGS 33C Portable Oxygen Generation System
FDA Enforcement
Class II
·Terminated·On Site Gas Systems Inc.·January 15, 2014