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
Newclip Patient-matched instrumentation non sterile PSI
Newclip Technics
CardIQ Suite
GE Medical Systems SCS
Turbo-Elite Laser Atherectomy Catheter
Spectranetics
T-FIX 3DSI Joint Fusion System
Cutting Edge Spine, LLC
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida F
Siemens Healthcare GmbH
BÜHLMANN fCAL® turbo and CALEX® Cap
Bühlmann Laboratories AG
VioSeal
Spident Co., Ltd.
Akunah REFLECT
Akunah Pty, Ltd.
eXciteOSA without remote control (3000); eXciteOSA with remote control (6000)
Signifier Medical Technologies, Ltd.
Treace Medical Concepts (TMC) Implant Fixation System
Treace Medical Concepts
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315)
Medtronic, Inc.
Pulse Oximeter
Shanghai Berry Electronic Tech Co., Ltd.
contact forte Alpha
Bhm-Tech Produktionsgesellschaft Mbh
SmartCardia 7L Platform (MCT)
Smartcardia SA
OSTEOPAL® V
Heraeus Medical GmbH
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
3M Company
Air Gap Fiber
Wontech Co., Ltd.
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/
Thermo Fisher Scientific
BellaTek Encode Emergence Healing Abutments
Biomet 3i, LLC
Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)
Zhejiang Rongsheng Industrial Co., Ltd.
EVOLUTION® Tibial Cones
Microport Orthopedics, Inc.
FemDx FalloView
Femdx Medsystems, Inc.
Insulin Syringe
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
Arthrex Vortex Threaded Bone Marrow Recovery Needle
Arthrex, Inc.
Electrosurgical Generator (ES-100); Electrosurgical Generator (ES-300)
Beijing Taktvoll Technology Co., Ltd.
Sonosite LX Ultrasound System
FUJIFILM Sonosite, Inc.
DuoprossTM Smart Cap (Type I)
Duopross Meditech Corporate
MAMMOMAT B.brilliant
Siemens Medical Solutions USA, Inc.
SCENARIA View Phase 5.0
Fujifilm Corporation
ZEPTO Precision Capsulotomy System
Centricity Vision, Inc.
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