14 results
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12ms
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Sources: EU EUDAMED, US FDA
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Enforcement
Class II
·Terminated·Boston Scientific Corporation·March 28, 2018
microTargeting" Drive System, Product Number MT-DS-01
FDA Enforcement
Class II
·Terminated·FHC, Inc.·July 11, 2018
GE Healthcare Innova IGS 3 (GTIN 00840682147378), Innova IGS 5 (GTIN 00840682124621), Innova IGS 6 (GTIN 00840682124614), Discovery IGS 7 (GTIN 00840682124638), and Discovery IGS 7 OR (GTIN00840682125888) interventional fluoroscopic x-ray systems.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 23, 2021
Baxter Electrocardiograph, ELI 380 -DCS21
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·February 1, 2023
Ultroid Sterile Disposable Probes sold individually
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
FDA Enforcement
Class II
·Terminated·Ultroid Technologies, Inc.·December 28, 2016
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·December 24, 2014
Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·February 20, 2013
Panorama Patient Monitoring Network Mindray DS USA The Panorama Patient Monitoring can view recal time, store, print, graph and trend patient clinical and demographic data. The Panoram Patient Monitoring Network can sent independent alarm limits for data send by the bedside monitor.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·May 4, 2016
V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
FDA Enforcement
Class II
·Terminated·Mindray DS USA, Inc. dba Mindray North America·July 23, 2014
Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets each comprised of the following 8 organisms: 1. S. Typhimurium derived from NCTC 74, 2. S. sonnei derived from NCTC 12984, 3. E. coli derived from CDC 2010C-3114 (STEC), 4. C. jejuni derived from NCTC 11322, 5. P. shigelloides derived from NCTC 10363, 6. Y. enterocolitica derived from NCTC 11174, 7. E. coli derived from NCTC 11602 (ETEC), 8. V. parahaemolyticus derived from NCTC 13209
FDA Enforcement
Class II
·Terminated·Microbiologics Inc·March 9, 2022
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019