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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