9 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARAMOUNT MINI GPS BILIARY STENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAPONICEL™
FDA UDI
ADVANCED MEDICAL SOLUTIONS LIMITED·15032749040650·ACTIVHEAL® RAPONICEL™ ULTRA 2.5X30.5CM
ARISTA LATINDO INDUSTRIAL, LTD. P.T.
FDA registration
ARISTA LATINDO INDUSTRIAL, LTD. P.T.·3 products·🇮🇩 Indonesia
AERONOX UNIVERSAL, MODEL P/N 360000, AERONOX BEDSIDE, MODEL P/N 360001, AERONOX TRANSPORT TRANSPORT, MODEL P/N 360002
FDA 510(k)
FDA Class 2
·Anesthesiology
AT HOME DRUG TEST, MODEL 9068 T
FDA 510(k)
FDA Unclassified
·Unknown
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·April 8, 2013
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 22, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 27, 2014
CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024