287 results
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22ms
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Sources: EU EUDAMED, US FDA
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI-BALLOON DETACHABLE BALLOON SYSTEM
Device, Vascular, For Promoting Embolization
FDA Pre-Market Approval
FDA Class 2
·MINI BALLOON
Triad
FDA UDI
Nuvasive, Inc.·00887517265043·Triad Cervical Rasp, 11x11x11mm
Washbon
FDA UDI
ORMCO CORPORATION·00889989043723·UPPER LEFT FIRST MOLAR WASHBON BAND SIZE 11
PECTUS BLU (TM)
FDA UDI
BIOMET MICROFIXATION, INC·00888233028783·
CONCHAPAK OXYGEN DILUTER
FDA 510(k)
FDA Class 1
·Anesthesiology
EYEVAN7285
FDA UDI
EYEVAN INC.·04571445047746·
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 6, 2014
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 10, 2012
REUSABLE CANNULAS -
FDA Adverse Event
Malfunction
·SMITH & NEPHEW ENDOSCOPY·Product code NBH·August 2, 2010
Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957
FDA Enforcement
Class II
·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024
Stent, Superficial Femoral Artery, Drug-Eluting
FDA Pre-Market Approval
FDA Class 3
·Eluvia Drug-Eluting Vascular Stent System