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
EndoSound Vision System; EVS
Endosound, Inc.
Eversense AP CGM System
Senseonics, Incorporated
Vigeon Laparoscopic Universal Smoke Evacuator (VG003)
Vigeon Technology Co., Ltd.
Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150
Covidien
Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
Honsun (Nantong) Co., Ltd.
Clarius AI
Clarius Mobile Health Corp.
Nexiva Closed IV Catheter System with NearPort IV Access
Becton Dickinson Infusion Therapy Systems, Inc.
NUVENTUS NV.C Prosthetic Components
Infinitum Eta, Ltd.
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
Ulike Co., Ltd.
Neu Platform
Neuhealth Digital , Ltd.
PlasmaFlow X Compression Sleeve Device (XPF0001)
Manamed, LLC
Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Humeris® 135 Shoulder System
Fx Shoulder USA, Inc.
Mouth Guard
ChangSha ChuangDuoLe E-Commerce Co., Ltd.
MAGNETOM Cima.X Fit
Siemens Medical Solutions USA, Inc.
Anti Grinding Guard
Xiamen Yizhou Imp. & Exp. Co., Ltd.
Diagnostic Ultrasound System (MX7); Diagnostic Ultrasound System (MX7T); Diagnostic Ultrasound System (Vaus7); Diagnosti
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
OTS Hip
Ortoma AB
Alere NT-proBNP for Alinity i Reagent Kit
Axis-Shield Diagnostics, Ltd.
Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186)
Joytech Healthcare Co. , Ltd.
Female IC (Not Finalized)
Hollister Incorporated
IPL Hair Removal Device
Shenzhen Goodwind Technology Development Co., Ltd.
AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down
Stryker Endoscopy
Human Lubricant
Jiangxi Wulinxiang Biological Technology Co., Ltd.
SLIT LAMP SL-D4 (Type: LED)
Topcon Corporation
CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
SuperBall Meniscal Repair System
Arcuro Medical , Ltd.
Transurethral Catheter Safety Valve (TUCSV) (80050)
Class Medical , Ltd.
ClotTriever Sheath
Inari Medical, Inc.
CWM-930S, FIXER DV9
Chungwoo Co., Ltd.
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