104 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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GENIUS¿ DIGITAL DIAGNOSTICS SYSTEM
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code QYV·April 28, 2026
GENIUS DIGITAL DIAGNOSTICS SYSTEM
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code QYV·May 26, 2026
GENIUS REVIEW STATION MONITOR
FDA Adverse Event
Malfunction
·HOLOGIC, INC.·Product code QYV·April 6, 2026
Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software Version: N/A - not software version specific Component: Yes, the Genius" Review Station is a component of the Genius" Digital Diagnostics System with the Genius" Cervical AI Algorithm cleared under DEN210035.
FDA Recall
Open, Classified
·Hologic, Inc·Product code QYV·March 23, 2026
Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
FDA classification
FDA Class 2
·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm
Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of diminutive polyps, sessile polyps, pedunculated polyps, and tissue from within the GI tract.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 19, 2025
Lyv Life Inc.
FDA registration
Lyv Life Inc.·6 products·🇺🇸 United States
1MED
FDA UDI
Qyk Brands LLC·00850039859465·1MED Surgical Mask, Level 2, Earloop style non-...
1MED
FDA UDI
Qyk Brands LLC·10850027748846·1MED Disposable Surgical Gown, Large, sterile
1MED
FDA UDI
Qyk Brands LLC·00850039859502·1MED Surgical Mask, Level 1, Earloop style non-...
1MED
FDA UDI
Qyk Brands LLC·00850039859472·1MED Surgical Mask, Level 3, Earloop style non-...
QG-40
FDA UDI
CARESTREAM HEALTH, INC.·60889971013897·QGV-40 Q-VISION GEN 40KW 1 PHASE
Aria Hybrid Valve
FDA UDI
CYPRESS ADAPTIVE, LLC·00850013242085·Aria Hybrid valve auto expulsion suction valve ...
LiNA CystoVu HD (CYV-100-5; CYV-101-5); LiNA ScopeVu (SCP-100-1)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LiNA CystoVu™ HD
FDA UDI
Lina Medical ApS·05708265013968·LiNA CystoVu™ HD, Single-use Flexible Cystoscop...
LiNA CystoVu™ HD
FDA UDI
Lina Medical ApS·05708265013944·LiNA CystoVu™ HD, Single-use Flexible Cystoscop...
LiNA CystoVu™ HD Biopsy Forceps
FDA UDI
Lina Medical ApS·05708265014095·6.9 Fr Biopsy Forceps
LiNA CystoVu™ HD Grasper
FDA UDI
Lina Medical ApS·05708265014118·5.4 Fr Rath Tooth Alligator Grasper
CYLOX ST
FDA UDI
SIGNUS Medizintechnik GmbH·04047844124291·The SIGNUS CYLOX® ST Interbody System is an ant...