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
Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear
Yung Sheng Optical Co., Ltd.
Single-use Ureteral Access Sheath
Hunan Vathin Medical Instrument Co., Ltd.
XERO-alpha
DRTECH Corporation
Cochlear Osia® System; Cochlear Osia® OSI300 Implant; Cochlear Magnet Cassette; Cochlear Non-Magnetic Cassette; Coch
Cochlear
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Critical Care Suite with Endotracheal Tube Positing AI algorithm
Ge Medical Systems, LLC
BE Plus PRO, Neurotravel LIGHT
Eb Neuro S.P.A.
Insignia Anterior Cervical Plate System
Alphatec Spine, Inc.
ONE Nitrile Condom
Global Protection Corp.
Synthetic Nitrile Examination Gloves
Shandong Hongxin Chemicals Co., Ltd.
GEM Premier ChemSTAT
Instrumentation Laboratory CO
AtriCure cryoICE BOX (ACM)
AtriCure, Inc.
Actively Trying Personal Lubricant Rose Scented
CC Wellness, LLC
R3 Large Head Liners
Smith & Nephew, Inc.
OGmend® Implant Enhancement System
Woven Orthopedic Technologies
Solero Microwave Tissue Ablation (MTA) System and Accessories
AngioDynamics, Inc.
Stryker MP, Mandible, HMMF and MMF AXS Screws
Stryker Leibinger GmbH & Co KG
Catalys Precision Laser System
Amo Manufacturing USA, LLC
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
Shenzhen Changkun Technology Co., Ltd.
AQUAbase nX
B.Braun Medical, Inc.
SnugFit ASA Extension
Medacta International S.A.
Clarius Prostate AI
Clarius Mobile Health Corp.
SmoothSkin Pure Unplugged (SSB3)
Cyden Limited
Imbio PHA (4.0.0)
Imbio, Inc.
Medical Surgical Mask
Nanchang Kanghua Health Materials Co., Ltd.
Zener® (model ZEN-001-B1)
Uvx, Inc.
medilogFD
Schiller AG
Surgical Face Mask
Shanghai Yunqing Industrial Co., Ltd.
Multi-Unit DAS System
Talladium España, SL
SIMDA Abutment
Simda Co., Ltd.
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