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
Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)
Midmark Corporation
Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co., Ltd.
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)
Arthrex FiberTape and TigerTape Cerclage Sutures
Arthrex, Inc.
SYMPHONY OCT System
Medos International SARL
Disposable Medical Nitrile Gloves
Changzhou Yihua Sanitation Material Co., Ltd.
restor3d TiDAL Lumbar Interbody Fusion Device
Restor3D
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH
Remington Medical, Inc.
Duet External Drainage and Monitoring System (EDMS)
Medtronic Neurosurgery
22.2mm BIOLOX® delta Ceramic V40 Femoral Heads
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Infrared thermometer
Shenzhen Yolanda Technology Co., Ltd.
Medical Surgical Mask
Azur Medical Company, Inc.
cobas HCV
Roche Molecular Systems, Inc.
Cellinew
VIOL Co., Ltd.
CytonPro-5000
Cytonsys, Inc.
RODIN Palette Naturalizing Kit
Belport Company, Inc., Gingi-Pak
Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3); Endoscopic Video Image Proc
Guangzhou Red Pine Medical Instrument Co., Ltd.
Jada System
Alydia Health
Augment Off-Axis Instrument System
Fix Surgical
Standard Bougie, 38 Fr. and Hand Pump
Standard Bariatrics
HS Fiber
Riverpoint Medical
BD Saf-T-Intima Subcutaneous Catheter System
Becton Dickinson Infusion Therapy Systems, Inc.
InferCare RECIST
Beijing Infervision Healthcare Medical Technology Co., Ltd.
ASEPT® Glide Peritoneal Drainage System
Pfm Medical, Inc.
Blood Pressure Monitor (TMB-2296-BT)
Guangdong Transtek Medical Electronics Co., Ltd.
Auxilock Titanium Screw-In Suture Anchor
Auxein Medical Private Limited
6F Wallaby Long Sheath
Wallaby Medical, Inc.
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
Hebei Titans Hongsen Medical Technology Co., Ltd.
Green Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn Bhd
iPredict-DR
iHealthscreen, Inc.
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