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
Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series
Chongqing Jinshan Science & Technology Co., Ltd.
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical Ltd. Dba Surmodics, Inc.
Z-LINKPC System
Zavation Medical Products, LLC
Impulse AM Interbody Fusion System
Degen Medical
SyMRI
Syntheticmr AB (Publ.)
Alma TED+ System
Alma Lasers, Inc.
Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible Ureteroscope (GY-UR8.4); Single-use Dig
Zhejiang Geyi Medical Instrument Co., Ltd.
Resolve Fundus Camera
Optain Health, Inc.
Wrist-type Fully Automatic Digital Blood Pressure Monitor
Joytech Healthcare Co. , Ltd.
FSYX Ocular Pressure Adjusting Pump
Balance Ophthalmics, Inc.
Vy Spine VySpan PCT System
Vy Spine, LLC
HERA W9, HERA W10 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with
Better Care Plastic Technology Co., Ltd.
TalWire
Embrace Medical , Ltd.
MultiPulse TFL
Asclepion Laser Technologies GmbH
AdheResp Smart Breath-actuated Mesh Nebulizer
Hcmed Innovations Co., Ltd.
SofWave System
Sofwave Medical, Ltd.
Tru Hematology Test
Truvian Sciences, Inc.
Quicktome Software Suite
Omniscient Neurotechnology Pty Ltd (O8t)
vPatch
Virility Medical
Fingertip Pulse Oximeter
Shenzhen Witleaf Medical Electronics Co., Ltd.
INHANCE Shoulder System, Sterile Single Use Instrumentation
Depuy Ireland UC
ACUSON SC2000 Diagnostic Ultrasound System
Siemens Medical Solutions USA, Inc.
MedWand
Medwand Solutions, Inc.
Promaxo MRI System II
Promaxo, Inc.
LYMA Laser PRO
Lyma Life , Ltd.
Dyna Locking Trochanteric Nail
Innosys
Surgical Face Mask (L 175*95mm)
Henan Chaoya Medical Equipment Co., Ltd.
Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
Changsha Anxiang Medical Technology Co., Ltd.
Nitrile Exam Gloves (Chemotherapy Drug Tested)
Us Medical Glove Company, LLC
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