11 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Disposable ureteral access sheath
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668101186·GILL CORNEAL KNIFE CURVED
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383553612·"An absorbent paper points is an endodontic pap...
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857369498·Trial, Size 12x14x14 mm, 0°
Storz Medical MAGNETOLITH Muscle Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
SYNERGY
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO, MED REL·Product code LGW·November 25, 2008
ALARIS SE BURETTE ADMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·July 28, 2011
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Enforcement
Class II
·Ongoing·Abbott Point Of Care Inc.·September 24, 2025
i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300
FDA Recall
Open, Classified
·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025