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
Gastric Alimetry System
Alimetry , Ltd.
IPL Hair Removal
Shenzhen Qiaochengli Technology Co., Ltd.
syngo.via MI Workflows; Scenium; syngo MBF
Siemens Medical Solutions USA, Inc.
sam 2.0 Long Ultrasound Device
ZetrOZ Systems, LLC
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Wontech Co., Ltd.
Hearing Aid Feature (HAF)
Apple, Inc.
Clear Aligners
Shenzhen Yinuo Dental Technology Co.Ltd
Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Periphera
Infraredx, Inc.
Medline Open-back Level 3 Protective Gown
Medline Industries, LP
Tesera-k ALIF System
Kyocera Medical Technologies, Inc.
FloPatch FP120
Flosonics Medical
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple
Jiangsu Bytech Medical Supplies Co., Ltd.
AIR Recon DL
Ge Medical Systems,Llc (Ge Healthcare)
Avanos* CORTRAK* 2 Enteral Access System (EAS)
Avanos Medical, Inc.
MOR
Morari, Inc.
Suture Button Repair System
Skeletal Dynamics, Inc.
EchoPAC Software Only / EchoPAC Plug-in
GE Medical Systems Ultrasound and Primary Care Diagnostics
Gnesis EMS Plus
Creative Fitness Developments S.L.
Dukal Corporation Level 1 Pediatric Face Mask
Dukal Corporation
Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary Care Diagnostics
EzDent-i/ E2/ Prora View/ Smart M Viewer
Ewoosoft Co., Ltd.
BunkerHill BMD
BunkerHill Health
CUSA® Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
SOTA Cloud Smart Sensor (1.5)
Sota Cloud Corp.
SIGNA Prime Elite
Ge Medical Systems, LLC
CoroFlow Cardiovascular System
Coroventis Research AB
Smile-100 System
Niramai Health Analytix Private Limited
Ponto 5 Mini
Oticon Medical AB
BE Plus PRO, Neurotravel LIGHT
Eb Neuro S.P.A.
Pre-Filled Normal Saline Flush Syringe
Anhui Tianyang Pharmaceutical Co., Ltd.
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