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
Mico One Orthodontic Screw
Ze Fang Technology Co., Ltd.
JetBoots PRO Plus
Therabody, Inc.
Power Mobility Scooter (MJMA01, MJMA02)
Nanjing Mijo Technology Co., Ltd.
Clarius Bladder AI
Clarius Mobile Health Corp.
VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium
Shenzhen Vitavitro Biotech Co., Ltd.
Vivo 3
Breas Medical AB
safety lancet
Tianjin Huahong Technology Co., Ltd.
PATHFAST®hs-cTnI-II
Phc Corporation
Equinoxe® Shoulder System
Exactech, Inc.
uMI Panorama
Shanghai United Imaging Healthcare Co., Ltd.
Lithoblast Single Use Holmium Laser Fibers
Dawell Medical, LLC
InVision Precision LVEF (LVEF)
InVision Medical Technology Corporation
Minuteman G5 MIS Fusion Plate
Spinal Simplicity, LLC
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Us
Hartalega NGC Sdn. Bhd.
Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
Tianjin Huahong Technology Co., Ltd.
MyEllevate
Cynosure, LLC
Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR1
Hunan Endoso Life Technology Co., Ltd.
IPL Hair Removal Device (BE932C, BE932D, BE932E)
Shenzhen Yang WO Electronic Co., Ltd.
QUANTUM® Patient Specific Instrumentation (PSI) System
In2bones Sas
MEMO Patch M (MPT-E08R-UNC01)
Huinno Co., Ltd.
High Retention Attachment System
Zest Anchors, LLC
SKR 3000
Konica Minolta, Inc.
Anatase Navi Disposable Instrument
Remex Medical Corp.
Smooth Drive contra angle and straight handpieces
Lares Research
Pulsenmore ES
Pulsenmore, Ltd.
IdentiTi ALIF Interbody Systems
Alphatec Spine, Inc.
Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd
Fixone Meniscal Repair
Aju Pharm Co., Ltd.
Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
Acuity Polymers, Inc.
Rosa® Knee System
Orthosoft Inc. (d/b/a) Zimmer CAS
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