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
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
Accurate Meditech, Inc.
RMU-2000 Automated Chest Compression System
Defibtech, LLC
Muscle Stimulator Device (PZ-100)
Zhengzhou PZ Laser Slim Technology Co., Ltd.
Second Opinion® Pediatric
Pearl, Inc.
Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3)
Ningbo Baichen Medical Devices Co., Ltd.
ARx Modular Spinal System
Life Spine, Inc.
Lyric4 Hearing Aid
Sonova AG
Annalise Enterprise
Harrison-AI Medical Pty, Ltd.
SmartSurgN Visualization System
Smartsurgn Incorporated
2.1 x 255mm Drill, 22mm Stop
Biomet Microfixation
Sphincterotome / short-wire compatible, Sterile Sphincterotome
Micro-Tech (Nanjing) Co., Ltd.
Pounce(TM) Sheath
Surmodics,Inc.
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Shanghai United Imaging Healthcare Co., Ltd.
VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (O
Shenzhen Vitavitro Biotech Co., Ltd.
Aqua Medical RF Vapor Ablation System
Aqua Medical, Inc.
Wearable Breast Pump (Model S12)
Shenzhen TPH Technology Co., Ltd.
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi
hCG One Step Pregnancy Test
Healstone Biotech, Inc.
MultiStage Balloon Dilatation Catheter
Dongguan TT Medical, Inc.
CUSTMBITE Snoring System
Dental Choice Holdings, LLC
URIS Long Implant & Abutments
Truabutment, Inc.
Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile)
Pt. Universal Gloves
ZENEX Implant System_Short (R-System)
Izenimplant Co., Ltd.
LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 E
GE Medical Systems Ultrasound and Primary Care Diagnostics
BreathID Hp System
Meridian Bioscience Israel , Ltd.
Disposable Syringe with Needle
Shandong Qinkai Medical Industry Co., Ltd.
BD Intelliport System; BD Intelliport Reader (516230); BD Intelliport Sensor (516229); BD Intelliport Gateway (516232);
Becton Dickinson
Stethophone Pro
Sparrow Acoustics, Inc.
Shani Darden LED light therapy mask
Harpar Grace International
R2 Dermabrasion Tip (for Dermal Cooling System)
R2 Technologies, Inc.
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