398 results
·
40ms
·
Sources: EU EUDAMED, US FDA
Filters
FDA Pre Market Approval
×
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PreVue Pre-loaded System, IPURE Pre-loaded System
FDA Pre-Market Approval
TOUCH® CMC 1 Prosthesis
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System
FDA Pre-Market Approval
PRE OP SPONGE
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus® UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test Pro Analyzer, PyloPlus Urea Breath Test Lab Analyzer
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus UBT System
Test, Urea Adult And Pediatric (Breath),
FDA Pre-Market Approval
FDA Class 3
·PyloPlus Urea Breath Test System
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·PreVue Pre-Loaded System
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·MOBILEXCIMER FOR PTK AND PRK
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Intraocular Lens
FDA Pre-Market Approval
FDA Class 3
·CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Sealant, Polymerizing
FDA Pre-Market Approval
FDA Class 3
·COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED)
Catheters, Transluminal Coronary Angioplasty, Percutaneous
FDA Pre-Market Approval
FDA Class 2
·R1S RAPID EXCHANGE PRE-DILATATION PTCA BALLOON CATHETER
Coronary Drug-Eluting Stent
FDA Pre-Market Approval
FDA Class 3
·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx®
Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors
FDA Pre-Market Approval
FDA Class 3
·AAV5 DetectCDx
Excimer Laser System
FDA Pre-Market Approval
FDA Class 3
·LASERVISION/VISX EXCIMER LASER FOR PRK AND PTK (MOBILEXCIMER)