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
SANSA HSAT
Huxley Medical
CuratOR EX3242-FD
Eizo Corporation
Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axo
Axogen Corporation
S.I.N. Dental Implant System
S.I.N. Implant System Ltda
JLK-ICH
JLK, Inc.
DermaSensor
Dermasensor, Inc.
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Medcad
IB3D PL Spinal System
Medicrea International S.A.S. (Medtronic)
ARX Liquid Amies Collection & Transport System
Arx Sciences, Inc.
SiJoin®T3
Vgi Medical, Inc.
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian A
SeaSpine Orthopedics Corporation
LCD Monitor (C1216W, C822W, C821W)
Shenzhen Beacon Display Technology Co., Ltd.
SmartAdjust Technology
Insulet Corporation
UbiqVue 2A Multi-parameter System (UX2550)
Lifesignals, Inc.
Q2 Blood Administration Sets
Quest Medical, Inc.
Diagnostic X-Ray Equipment Model POCT22
Ningbo Runyes Medical Instrument Co., Ltd.
Sunsphere
Hangzhou Yangshun Medical Technology Co.,Ltd
Vital Signs
Oxehealth Limited
Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit
Zhejiang Longterm Medical Technology Co., Ltd.
iQFlex Pro
First Source, Inc.
One-Fil Putty
Mediclus Co., Ltd.
Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)
Polybell (Guangzhou) Limited
Silkn Toothwave
Home Skinovations , Ltd.
Arctic Sun Temperature Management System (Model 5000)
Medivance, Inc.
1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)
Stryker
CEREC Tessera Abutment System
Dentsply Sirona
Miru 1day UpSide (midafilcon A)
Menicon Co, Ltd.
C&B Ceramic; C&B Permanent; C&B Interim
Prevest Denpro Limited
Reprocessed NRG Transseptal Needle
Innovative Health, LLC
Aventus Thrombectomy System (IM-2100)
Inquis Medical
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert