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
XR-Series (XR-10, XR-20) Automated Hematology Analyzers
Sysmex America, Inc.
Any-Etch
Mediclus Co., Ltd.
Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds,
Baisheng Medical Co., Ltd.
Mobility Scooter (Model X-01, X-02)
Wuyi Aichi Industry & Trade Co., Ltd.
CARA System
Cara Medical, Ltd.
FreeStyle Libre 3 Continuous Glucose Monitoring System
Abbott Diabetes Care, Inc.
ASAP Aspiration Catheter, ASAPLP Aspiration Catheter
Merit Medical Systems, Inc.
SpO2 Extension Cable
Beijing Rongrui-Century Science & Technology Co., Ltd.
Cryo-Thermo Compression Device (FGK002)
Suzhou Microport Rehabtech (Group) Co., Ltd.
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
Yian Medical Technology (Haining) Co., Ltd.
Arrow Pressure Injectable Midline Catheter
Arrow International, LLC Subsidiary of Teleflex Incorporated
Calibrate Interbody Systems
Alphatec Spine, Inc.
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
F3
Acrew Imaging, Inc.
GMK 3D Metal Tibial Tray
Medacta International S.A.
PolyWear® Personal Protective Level 3 Gown
PolyConversions, Inc.
Erchonia DPN Laser (Model# EVRL)
Erchonia Corporation
17HQ701G-B
Lg Electronics.Inc
Endophys Blood Pressure Monitor model BPM-30
Endophys Technologies, LLC
SF Push- in Anchor
Surgical Fusion Technologies GmbH
Iconix Speed Anchor; Iconix Speed HA+ Anchor
Riverpoint Medical
Disposable Endoscope Valves Set (AF series)
Alton (Shanghai) Medical Instruments Co., Ltd.
Distal Humerus Plating System
Skeletal Dynamics, Inc.
EMBOGUARD Balloon Guide Catheter
Neuravi Limited
Leaderflex Mini and Leaderflex Nano
Vygon USA
EFAI ChestSuite XR Pleural Effusion Assessment System
Ever Fortune.Ai, Co., Ltd.
Ultraviolet Phototherapy Device
APK Technology Co., Ltd.
Gingi-Aid Gel
Belport Company, Inc., Gingi-Pak
Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drug
Sentienx Sdn Bhd
Osstem Implant System
Osstem Implant Co., Ltd.
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