10 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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Aviator Anterior Cervical Plate (ACP) System
FDA 510(k)
FDA Class 2
·Orthopedic
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526550162·GENUMEDI PT KNEE SUP SILVER L EW VII
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814244·GENUMEDI PT SILVER L VII
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704508468·GENERAL SCISSORS STRAIGHT 9" TUNGSTEN CARBIDE
PVS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
EBI PERIARTICULAR PLATING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code LZG·October 5, 2014
PRIMEADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 3, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 28, 2011
Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. 3. Model Number (REF): 782103. 510(k) Numbers: K163116, K173079, K183063, K193215, K213516, K213583, K223458, K251397, K251808
FDA Enforcement
Class II
·Ongoing·Philips North America·May 6, 2026