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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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