510(k) Device Clearances
Medical devices cleared through the FDA's 510(k) premarket notification process. Substantially equivalent to existing devices.
15,000 total clearances
GEM ZIPCLIP
Synovis Micro Companies Alliance A Subsidiary of Baxter Int
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
Pall Corporation
AngioVac Cannula
AngioDynamics, Inc.
MOSES Raydar
Boston Scientific Corporation
SafetiHeel, MediHeel, Novaplus
Nsp Tech Pte, Ltd.
BioFire COVID-19 Test 2
Biofire Defense, LLC
Safecare Urinary Tract Infection Test
Safecare Biotech (Hangzhou) Co., Ltd.
Well-Root PT
Vericom Co., Ltd.
EMPOWR Revision Knee
Encore Medical L.P.
Wesper Lab
Wesper, Inc.
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
Arftx Medical, LLC
Franz Zirconia Dental Crown
Franz Biotech, Inc.
EzDent-i / E2 / Prora View/ Smart M Viewer
Ewoosoft Co., Ltd.
JO CUMPLAY Personal Lubricant
CC Wellness, LLC
Apapro Desensitizer
Sangi Co., Ltd.
Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)
Cresilon, Inc.
DRX9000C-SL Cervical Spinal Decompression System
Excite Medical of Tampa Bay, LLC
NIKKICART
Renal Care Dialysis Solutions, S.A. DE C.V.
F65 Laser System
Lumenis Be, Ltd.
AlloMap Heart Molecular Expression Testing
Caredx, Inc.
Polyver Silver Alginate Dressing (Prescription and OTC)
Roosin Medical Co., Ltd.
syngo.CT Dual Energy
Siemens Medical Solutions USA, Inc.
Anterior Spine Truss System-Stand Alone (ASTS-SA)
4Web Medical, Inc.
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Ortho Clinical Diagnostics
HP PTA Balloon Dilatation Catheter
Kossel Medtech (Suzhou) Co., Ltd.
Prolystica Pass Thru Disinfectant Wipes
Steris
EM-07 Cordless Endo Motor
Forum Engineering Technologies (96) , Ltd.
da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
CANON Fundus Camera CR-10 (CR-10)
Canon, Inc.
VALORY
Agfa N.V.
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