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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

SANSA HSAT

Huxley Medical

CuratOR EX3242-FD

Eizo Corporation

Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard HA+ Nerve Protector (AGHA24); Axo

Axogen Corporation

S.I.N. Dental Implant System

S.I.N. Implant System Ltda

JLK-ICH

JLK, Inc.

DermaSensor

Dermasensor, Inc.

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

Medcad

IB3D™ PL Spinal System

Medicrea International S.A.S. (Medtronic)

ARX Liquid Amies Collection & Transport System

Arx Sciences, Inc.

SiJoin®T3

Vgi Medical, Inc.

Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian A

SeaSpine Orthopedics Corporation

LCD Monitor (C1216W, C822W, C821W)

Shenzhen Beacon Display Technology Co., Ltd.

SmartAdjust™ Technology

Insulet Corporation

UbiqVue™ 2A Multi-parameter System (UX2550)

Lifesignals, Inc.

Q2 Blood Administration Sets

Quest Medical, Inc.

Diagnostic X-Ray Equipment Model POCT22

Ningbo Runyes Medical Instrument Co., Ltd.

Sunsphere

Hangzhou Yangshun Medical Technology Co.,Ltd

Vital Signs

Oxehealth Limited

Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit

Zhejiang Longterm Medical Technology Co., Ltd.

iQFlex Pro

First Source, Inc.

One-Fil Putty

Mediclus Co., Ltd.

Electric Breast Pump (BH627, BH628, BH707, BH709, BH813, BH816, BH110, H701, H1129, H1128, H620, H705, H706)

Polybell (Guangzhou) Limited

Silk’n Toothwave

Home Skinovations , Ltd.

Arctic Sun Temperature Management System (Model 5000)

Medivance, Inc.

1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130)

Stryker

CEREC Tessera Abutment System

Dentsply Sirona

Miru 1day UpSide (midafilcon A)

Menicon Co, Ltd.

C&B Ceramic; C&B Permanent; C&B Interim

Prevest Denpro Limited

Reprocessed NRG Transseptal Needle

Innovative Health, LLC

Aventus Thrombectomy System (IM-2100)

Inquis Medical

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