53 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
FDA 510(k)
FDA Class 2
·Cardiovascular
ambIT
FDA UDI
SUMMIT MEDICAL PRODUCTS, INC.·00850000509009·ambIT Kit Basic w Male Luer & Filter Cassette
ambIT*
FDA UDI
Avanos Medical, Inc.·00193494000356·ambIT* RPS Kit-Male Luer Cassette with Filter *
ELMED
FDA UDI
ELMED INCORPORATED·00842180121041·5 MM DIA., 33 CM INSULATED SLING TIP ELECTRODE ...
BALLARD™
FDA UDI
SUNMED, LLC·10889483623428·BALLARD™ CLOSED SUCTION SYSTEM FOR ADULTS, T-Pi...
Ballard* Closed Suction System for Adults
FDA UDI
Avanos Medical, Inc.·00609038983080·BALLARD* Closed Suction Catheter, T-Piece, WET ...
AKUPORT M-2
FDA 510(k)
FDA Class 2
·Neurology
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·March 28, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 6, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·November 19, 2024
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·May 14, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 6, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·July 3, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 6, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·November 21, 2024
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·November 6, 2024
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·November 18, 2024
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·August 6, 2025
OPTICROSS 18
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code OBJ·September 16, 2025