9 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
×
VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.
FDA Enforcement
Class III
·Terminated·ORTHO-CLINICAL DIAGNOSTICS·July 20, 2016
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges.
FDA Enforcement
Class III
·Terminated·Abbott Point Of Care Inc.·November 14, 2012
To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A
FDA Enforcement
Class III
·Ongoing·Olympus Corporation of the Americas·May 31, 2023
ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract. Model: NA-U401SX-4021, NA-U401SX-4021-A
FDA Enforcement
Class III
·Ongoing·Olympus Corporation of the Americas·May 31, 2023
T/Pump temperature therapy pump, Models TP700 and TP700C
FDA Enforcement
Class III
·Terminated·Stryker Medical Division of Stryker Corporation·March 21, 2018
Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·February 18, 2015
Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·May 13, 2015
RF MultiGen¿, 0406-900-000; Refurb RF MultiGen¿, 0406-900-000U
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·November 23, 2016
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
FDA Enforcement
Class III
·Terminated·Stryker Instruments Div. of Stryker Corporation·July 27, 2022