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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.

3,400 total clearances

Rectal Applicator

Nucletron B.V.

Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula

Restore Robotics

Arise™ UHP Dilatation Catheter

Creagh Medical, Ltd.

DNA/RNA Shield SafeCollect Saliva Collection kit

Zymo Research

Quick-Start Screws

Innovate Orthopaedics Limited

TORPEDO Implant System®

Deltacor GmbH

DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)

Pro Med Instruments GmbH

Boehringer Laboratories Liver Retractor

Boehringer Laboratories, LLC

Microwave Ablation Device

Nanjing Dewen Medical Technology Co., Ltd.

ORAcollect®•Dx

DNA Genotek, Inc.

Aptima HCV Quant Dx Assay

Hologic, Inc.

Light Based Hair Removal Device GP592

Shenzhen Gsd Tech Co., Ltd.

F3

Acrew Imaging, Inc.

KARL STORZ Monopolar Resectoscopes with HF Cable

Karl Storz SE & CO. KG

Archy Dental Imaging

Archy Dental, Inc.

PolyWear® Personal Protective Level 3 Gown

PolyConversions, Inc.

Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge

Chirurgie Innovation

1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM

Stryker

AllTest Fentanyl Rapid Test (Urine)

Hangzhou AllTest Biotech Co., Ltd.

Tesera-k PL System and Tesera-k XL System

Kyocera Medical Technologies, Inc.

Luja Coude (20108 Male CH18 - large packaging)

Coloplast Corp.

ADRx™ Admixture Device

Epic Medical Pte. , Ltd.

Merits P335 Powered Wheelchair

Merits Health Products Co., Ltd.

PicoLO Premium

Laseroptek Co., Ltd.

EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasou

Cook Ireland, Ltd.

TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System

Life Spine, Inc.

NIM Essence™ EMG Endotracheal Tube (NIMEID060); NIM Essence™ EMG Endotracheal Tube (NIMEID065); NIM Essence™ EMG Endotra

Medtronic Xomed, Inc.

Aventus Thrombectomy System

Inquis Medical

DeepTek CXR Analyzer v1.0

Deeptek Medical Imaging Pvt, Ltd.

Q-Switched Nd:Yag laser

Hebei Zhemai Technology Co., Ltd.

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