Related by context. Frequent words. (Click for all words.) 66 k Clearance 60 FDA Clearance 57 Market Approval PMA 57 CE Marking 56 CE Marked 55 Investigational Device Exemption IDE 53 Humanitarian Device Exemption 52 received CE Marking 51 Drug Administration FDA 51 Investigational Device Exemption 50 MONOVISC 50 MitraClip R 50 Sonablate R 49 Stent System 49 Receives FDA Clearance 49 CORTOSS 49 FDA Approval 49 Orphan Drug status 49 SFDA approval 49 exemption IDE 48 Orphan Drug designation 48 USFDA approval 48 Supplemental Type 48 Coronary Stent System 47 ComfortScan system 47 CADstream 47 Fast Track designation 47 Marketing Authorization Application MAA 47 Receives CE 47 Orphan Drug Status 46 GEM #S 46 excimer laser 46 Zelrix 46 Biologics License Application 46 Marketing Authorization 46 Welfare MHLW 45 Endeavor stent 45 Coronary Stent 45 regulatory approval 45 Orphan Drug Designation 45 ISO #:# certification [001] 44 Fast Track Designation 44 injectable formulation 44 vitro diagnostic IVD 44 CXA 44 FIRAZYR 44 Bone Graft 44 Augment Bone Graft 44 Uracyst ® 44 Omigard 44 Surgical System 44 Destination Therapy 44 Uracyst 44 Complete Response letter 44 EndoBarrier 44 Abstral 43 Uracyst R 43 New Drug Application 43 ExAblate 43 ELAPRASE 43 BioGlue 43 investigational 42 Biologics License Application BLA 42 Vasovist 42 Drug Eluting Stent 42 FDA approvable letter 42 orphan designation 42 ISO Certification 42 Approvable Letter 42 sBLA 42 PillCam COLON 42 VentrAssist 42 Implant 41 Drug Administration USFDA 41 OsteoGram 41 brachytherapy seeds 41 High Intensity Focused 41 Clinical Trial Application 41 pulse oximeters 41 SilverHawk 41 Microspheres 41 requisite regulatory approvals 41 CCHIT Certified 41 Bovie 41 Terumo Corporation 41 Phase III pivotal 41 ATryn 41 Dupuytren contracture 40 Reloxin 40 THELIN 40 Pennsaid R 40 Act PDUFA date 40 application sNDA 40 approvable letter 40 KRYSTEXXA 40 vascular graft 40 BEMA Fentanyl 40 Surgical Adhesive 40 Macroplastique 40 CyberKnife Robotic Radiosurgery System 40 FIPS #-# certification