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
Dental sensors NanoPix1, NanoPix2
Iray Technology Taicang , Ltd.
uCerv Flux-C 3D Porous Titanium Cervical Interbody
Ulrich Medical USA, Inc.
OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor
Riverpoint Medical
Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M); Single Use Non-Stick Jewelle
Hg Innovations, Ltd.
Intra.Ox 2.0 Handheld Tissue Oximeter
Vioptix, Inc.
Aura 10 PET/CT
Xeos Medical
Preat Abutments
Preat Corporation
Polyisoprene Surgical gloves
Suzhou Colour-Way New Material Co., Ltd.
BruxZir Esthetic
Prismatik Dentalcraft, Inc.
coactiv+ Antimicrobial Wound Gel
Kane Biotech, Inc.
Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter
Medtronic
Surgical Face Mask
Xiantao Deming Healthcare Products Co., Ltd.
Zavation Navigation Instrument System
Zavation Medical Products, LLC
Remex KA6
Remedi Co., Ltd.
Endoskeleton Interbody Systems
Medtronic Sofamor Danek USA, Inc.
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
Devilbiss Healthcare, LLC
Suture Button Repair System
Skeletal Dynamics, Inc.
ICEfx Cryoablation System (FPRCH8000-02)
Boston Scientific
Paneffort 3-ply Surgical and Procedural Masks
Paneffort, LLC
Real Intelligence Cori
Blue Belt Technologies, Inc.
FreeStyle Comfort (AS200 / FreeStyle Comfort)
Caire, Inc.
MiVu Esophageal Endo Cap
Diversatek Healthcare
uCT 780 with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
Beijing HuaCheng Taike Technology Co., Ltd.
CONMED Argo Knotless® Anchor
Conmed Corporation
Varion Thoracolumbar Fixation System
Kyocera Medical Technologies Inc. (KMTI)
Locking Screw,CoCrMo
Double Medical Technology, Inc.
AT-Patch (ATP-C130/ATP-C70)
Atsens Co., Ltd.
Arthrex Vortex Threaded Bone Marrow Recovery Needle
Arthrex, Inc.
iQ-solutions
Sydney Neuroimaging Analysis Centre Pty, Ltd.
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