9 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
Polystar Selection EDITION HD
FDA UDI
Merz Dental GmbH·D7091983145·posteriors; shade BL3; size XL; lower jaw
9831 - F-Socket Sensor
FDA UDI
Tekscan, Inc.·B9709831450·9831 - F-Socket Sensor
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
FDA 510(k)
FDA Class 2
·Cardiovascular
IlluminOss Photodynamic Bone Stabilization System
FDA 510(k)
FDA Class 2
·Orthopedic
8 MM TIP COVER ACCESSORY
FDA Adverse Event
Injury
·INTUITIVE SURGICAL,INC.·Product code NAY·February 28, 2013
LIFEPAK 9 DEFIBRILLATOR/MONITOR
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code LDD·January 31, 2011
UNK
FDA Adverse Event
Malfunction
·HOSPIRA, LTD.·Product code FPA·July 2, 2014
Podiatry Pack, part number AMS2778 Podiatry Pack, part number AMS2778(A Podiatry Pack, part number AMS3785(B Podiatry Pack, part number AMS3785(C Podiatry Pack, part number AMS4011(A Podiatry Pack, part number PSS3422(A
FDA Enforcement
Class II
·Terminated·Windstone Medical Packaging, Inc.·March 8, 2017