48 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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GENOSYL DS (Delivery System) console, for use as a vasodilator.
FDA Enforcement
Class I
·Completed·Vero Biotech, LLC·October 6, 2021
GENOSYL DS (Delivery System) console, for use as a vasodilator.
FDA Recall
Completed
·Vero Biotech, LLC·Product code MRN·September 9, 2021
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Enforcement
Class II
·Completed·Hologic, Inc·December 18, 2024
Hologic Sizer Set- sterilization tray and 6 individual sizers, intended as a Surgical instrument guide Model/Catalog Number: F0101
FDA Recall
Completed
·Hologic, Inc·Product code FZX·October 10, 2022
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
MassChrom Cortisol, Cortisone Saliva Control Level II, Order No. 0350 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020
MassChrom Cortisol, Cortisone Saliva Control Level I, Order No. 0349 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JJY·October 29, 2020
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Enforcement
Class II
·Completed·Chromsystems Instruments & Chemicals GmbH·December 9, 2020
6PLUS1 Multilevel Saliva Calibrator Set Cortisol Cortisone in Saliva, Order No. 73039 - Product Usage: The kit is used as a test for patients to monitor their cortisol and cortisone levels.
FDA Recall
Completed
·Chromsystems Instruments & Chemicals GmbH Am Haag 12 Grafelfing Germany·Product code JIX·October 29, 2020
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
FDA Enforcement
Class II
·Completed·Stryker Corporation·June 13, 2018
3910-090-800 ASSY, PKG, 8.0MM X 90MM DRI-LOK THREADED CANNULA, 5 units per box. The Disposable Cannula device is designed to be used as a port of entry for arthroscopic instruments into the joints.
FDA Recall
Completed
·Stryker Corporation·Product code PPR·December 21, 2017
Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt dissection of tissue, Model Number KT-9101
FDA Enforcement
Class II
·Completed·ASPEN SURGICAL·July 3, 2024
Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781356
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781357
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781359
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781271
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021
Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781358
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021