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
Joule diVa System
Sciton, Inc
REMEX Xcam6
Remedi, Inc.
Contour® next GEN Blood Glucose Monitoring System
Ascensia Diabetes Care
Disposable Laryngeal Electrodes
Suzhou Haishen Medical Device Associates Co., Ltd.
Cervical Plate System
Double Medical Technology, Inc.
Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®
Centerline Biomedical, Inc.
Disposable Medical Mask
Hubei Wanli Protective Products Co., Ltd.
DENU Composite Resin, DENU Flow Resin
Hdi, Inc.
Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617)
Shenzhen Urion Technology Co., Ltd.
Integrity-SI® Fusion System
OsteoCentric Technologies
Muscle Stimulator
Shenzhen Yiran Intelligent Co., Ltd.
DistaSense(TM) (v1)
Life Detection Technologies
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co., Ltd.
Lymphedema Compression
Jkh Health Co., Ltd.
MF SC GEN2 Facial Toning System
Micro Current Technology, Inc.
Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe
CMT Health PTE., Ltd.
aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interf
Carlsmed, Inc.
NemoScan
Software Nemotec S.L.
URIS Smart Path Implant System & Prosthetic
Truabutment, Inc.
LAGIS Suction Irrigation System
Lagis Enterprise Co., Ltd.
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 wit
Qura S.R.L
Body Temperature Software (BTS)
Fitbit, LLC
LYNX Photocoagulator
Norlase Aps
LAITEST Medical Face Mask
R&R Medical Corporation, Ltd.
Altis Single Incision Sling System
Coloplast A/S
3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355
3M Company
Everyway Incontinence Stimulation System
Everyway Medical Instruments Co.,Ltd
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
Hunan Ceramaster Material Technology Co., Ltd.
xvision Spine System
Augmedics, Ltd.
Raney Clips Kit
Beijing Honghugaoxiang Science and Technology Development CO
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