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
PHantom Trilogy
Resurgeonz, LLC
Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technology Co., Ltd.
CORIOGRAPH Pre-Op Planning and Modeling Services
Blue Belt Technologies, Inc.
Sherlock
Open Implants, LLC
Coaptium Connect with Tissium Light
Tissium SA
Cervical Plate System
Double Medical Technology, Inc.
Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
Ge Medical Systems Information Technologies, Inc.
NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellan
Hycor Biomedical
Accoat Guide Wire
Sp Medical A/S
dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
Dentona AG
Marrow Marxman
Medimetrix, LLC
Anovo Surgical System (Model 6Ne)
Momentis Surgical , Ltd.
MSS - Monobloc stem
Medacta International S.A.
Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)
Shanghai SeeGen Photoelectric Technology Co., Ltd.
NorthStar Mapping System (MAP01 or MAP01-01)
Imricor Medical Systems, Inc.
Vashe Plus Antimicrobial Solution
Urgo Medical North America, LLC
Evidence MultiSTAT DOA Urine MultiPlex
Randox Laboratories Limited
staysafe® catheter extension set with Safe- Lock, 12 inch; staysafe® catheter extension set with Luer-Lock, 6 inch; st
Fresenius Medical Care Renal Therapies Group, LLC
NeoSpan® Compression Implant System
In2bones USA, LLC
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
Boston Scientific Corporation
Elecsys Tg II
Roche Diagnostics
zirkon; structure; LFU shades, stains and glazes
Estetic Ceram AG
Overture Orthopaedics Patellofemoral System
Overture Resurfacing, Inc.
Apollo Quattro (APQ-10M)
Weero Co., Ltd.
Sensinel Cardiopulmonary Management (CPM) System (ADCP1100)
Analog Devices
Three Way Stop Cock
M/S Romsons International
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTr
Stryker Spine
Wrist Fracture System
Met One Technologies, LLC
MuscleView
Springbok, Inc.
Wave Electrode (AE02-60); Wave Electrode (AE02-50)
Bionit Labs Srl
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