248 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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OT SELECT SIMPLE METER
FDA Adverse Event
Injury
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code PYV·November 13, 2018
Hospital Continuous Glucose Monitoring System
FDA classification
FDA Class 2
·Hospital Continuous Glucose Monitoring System
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
PDV MedTech
FDA registration
PDV MedTech·12 products·🇺🇸 United States
Lyv Life Inc.
FDA registration
Lyv Life Inc.·6 products·🇺🇸 United States
PGV-20
FDA UDI
KOVEN TECHNOLOGY, INC.·00894912002203·PPG and Pulse Volume combo module for Smartdops.
Phased array probe
FDA UDI
CHISON Medical Technologies Co., Ltd.·06945121411417·
Aria Hybrid Valve
FDA UDI
CYPRESS ADAPTIVE, LLC·00850013242085·Aria Hybrid valve auto expulsion suction valve ...
PLAQUAGRAFE, AGRAFE P4V
FDA 510(k)
FDA Class 2
·Orthopedic
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...
METRO-PACIFICA
FDA UDI
Metro Medical Supply·00609626000076·Patient Examination Gloves Powder-Free Vinyl S
CYLOX ST
FDA UDI
SIGNUS Medizintechnik GmbH·04047844124260·The SIGNUS CYLOX® ST Interbody System is an ant...
CYLOX ST
FDA UDI
SIGNUS Medizintechnik GmbH·04047844124253·The SIGNUS CYLOX® ST Interbody System is an ant...
CYLOX ST
FDA UDI
SIGNUS Medizintechnik GmbH·04047844124499·The SIGNUS CYLOX® ST Interbody System is an ant...