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
Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws
Avanti Orthopaedics, Inc.
AirKEE T900
Healkee Medical Pte, Ltd.
ICEfx Cryoablation System (FPRCH8000-02)
Boston Scientific
UV Smart D60
UV Smart Technologies B.V.
Hair Growth Comb (SZ-23,SZ-23A)
Shenzhen Nuon Medical Equipment Co., Ltd.
HOTWIRE RF Guidewire
Atraverse Medical
Zeta Navigation System
Zeta Surgical, Inc.
CATAMARAN SI Joint Fusion System
Tenon Medical, Inc.
Portable Folding Electric Wheelchair (Model: DC01)
Anhui Jbh Medical Apparatus Co., Ltd.
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
Momcozy Wearable Breast Pump (BP223)
Shenzhen Root Innovation Technology Co., Ltd.
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
Edwards Lifesciences, LLC
iCAS-LV
Highrad , Ltd.
Limfa Therapy System (Limfa Therapy)
Eywa Srl
Perfit CL
Vatech Mcis Co., Ltd.
SCENARIA View Phase 5.0
Fujifilm Corporation
iQ-solutions
Sydney Neuroimaging Analysis Centre Pty, Ltd.
RevoLix HTL
Lisa Laser Products GmbH
Everion+ System
Biofourmis Singapore Pte., Ltd.
STRUXXURE® MCS Anterior Cervical Plate System
Nexxt Spine
AMStent® Tracheobronchial Covered Stent System
Peytant Solutions, Inc.
da Vinci E-200 Electrosurgical Generator
Intuitive Surgical
injeTAK Adjustable Tip Needle (DIS199; DIS201)
Laborie Medical Technologies, Corp.
Lunit INSIGHT MMG
Lunit, Inc.
iCare APP
Ihealth Labs, Inc.
CoLink NeoFuse Plating System
In2bones USA, LLC
XO Cross Support Catheter
Transit Scientific, LLC
AspenView
Aspen Imaging Healthcare, Inc.
IPL HAIR REMOVAL HANDSET, Model: IPL-666
Shenzhen Junbobeauty Technology Co., Ltd.
DEKA Loop
Deka Research and Development
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