102 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in; 25 units per box. Vital Signs Inc. a GE Healthcare Company, 20 Campus Road, Totowa, NJ 07512 USA, www.gehealthcare.com/vitalsigns. Continuous temperature monitoring.
FDA Enforcement
Class II
·Terminated·Vital Signs Devices, a GE Healthcare Company·August 21, 2013
Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy. The neurostimulators are multiprogrammable devices that accommodates a lead through which a stimulation program is delivered. The Medtronic Enterra Neurostimulator, Model 3116, is part of an Enterra Therapy system for gastric electrical stimulation (GES). The neurostimulator is a multiprogrammable device that accommodates a lead through which a stimulation program is delivered.
FDA Enforcement
Class II
·Terminated·Medtronic Neuromodulation·March 4, 2015
GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes Snubber Boards are a PCB with a 70 amp fuse to provide fused protection of internal system components from the high voltage system components, such as the X-ray tube or High Voltage Transformer. System model number A349855, Snubber Board number 00-880405-03 rev 5. This product is used for image intensified fluoroscopic x-rays for interventional radiologic procedures.
FDA Enforcement
Class II
·Terminated·GE OEC Medical Systems, Inc·August 29, 2012
Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19
FDA Enforcement
Class II
·Terminated·TriMed Inc.·June 27, 2018
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
FDA Enforcement
Class II
·Ongoing·CareFusion 303, Inc.·May 17, 2023
Food Intolerance Test Small
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Lactose Intolerance Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Mycotoxin Panel Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Fructose Intolerance Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Intestinal Worms Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Iodine Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Menopause (FSH) 2 Tests
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Biological Age & Longevity Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Iron Deficiency Test (ferritin)
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Men s Hormone Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
IBS Test
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025
Gut Microbiome Test Medium
FDA Enforcement
Class II
·Ongoing·GET TESTED INTERNATIONAL AB·December 10, 2025