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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IPL Home Use Hair Removal Device
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776416232·Sinus Curette, Double Ended Mini Spoon, Angled/...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450639931·
ENDOTAK DOWN-SIZED PLUS
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS·Product code LWS·May 8, 1997
POWDERED LATEX EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
VOCARE MYHEALTH TABLET
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 29, 2014
PRECISION XTRA
FDA Adverse Event
Malfunction
·Product code NBW·August 15, 2011
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·July 8, 2013
H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
FDA Enforcement
Class I
·Terminated·Smiths Medical ASD, Inc.·September 3, 2014