25 results
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12ms
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Sources: EU EUDAMED, US FDA
Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.
FDA Enforcement
Class I
·Terminated·Western / Scott Fetzer Company·July 29, 2015
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
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
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
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
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
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
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·January 22, 2014
MOL3650 Simplexa VZV Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster virus (VZV) DNA in cerebrospinal fluid (CSF) from patients with signs and symptoms of VZV infections of the central nervous system (CNS).
FDA Enforcement
Class II
·Terminated·DiaSorin Molecular LLC·July 22, 2020