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
Cardiologs Holter Platform
Philips France Commercial
TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)
Shenzhen Jiantuo Electronics Co., Ltd.
Alinity i Total ß-hCG Reagent Kit, GLP systems Track
Abbott Laboratories
Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with
Better Care Plastic Technology Co., Ltd.
EXPLORER AIR® II
Surgvision GmbH
Nutrifit
Vygon USA
AcQMap High Resolution Imaging and Mapping System
Acutus Medical, Inc.
KLS Martin Neuro Rongeurs
KLS-Martin L.P.
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
Roche Diabetes Care GmbH
CEFALY Connected - OTC, CEFALY Connected - Rx
Cefaly Technology
KardiaMobile 6L
AliveCor, Inc.
da Vinci E-200 Electrosurgical Generator
Intuitive Surgical
Unity Knee PS-C Tibial Insert
Corin U.S.A. Limited
Medical Diode Laser (S1Pro)
Wuhan Pioon Technology Co., Ltd.
Purgo
Aeroclean Technologies, LLC
MeMed BV
MeMed Diagnostics, Ltd.
ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnosti
Siemens Medical Solutions USA, Inc.
Philips MR Patient Care Portal
Invivo Corporation
N2
Megagen Implant Co., Ltd.
Amputee Garment for use with Lympha Press Optimal Plus
Mego Afek AC , Ltd.
Monotime and Optime R
Peters Surgical
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Esthetic Medical, Inc.
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.Ai, Co., Ltd.
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD
Biomérieux
Aspira Pleural Drainage System
Merit Medical Systems, Inc.
Amferia Wound Dressing
Amferia AB
Sentinel Camera
Ai Optics
Constellation (CON-001)
Q Bio, Inc.
Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet)
Beijing Adss Development Co., Ltd.
Geister K-Rex rongeurs
Geister Medizin Technik GmbH
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