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
Salix Coronary Plaque (V1.0.0)
Artrya Limited
Avitus® DragonWing Large Volume Autograft Delivery System
Avitus Orthopaedics, Inc.
da Vinci SP Surgical System (SP1098)
Intuitive Surgical, Inc.
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT)
Orthocon, Inc.
Cala kIQ Plus
Cala Health, Inc.
Getinge GSS67N Series Steam Sterilizer
Maquet GmbH (A Getinge Group Company)
Hybrid Viewer (00859873006189)
Hermes Medical Solutions AB
OSSIOfiber® Suture Anchor 2.5-3.5 mm
OSSIO , Ltd.
Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
Hl Rubber Industries Sdn Bhd
Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc.
Temporary Keratoprosthesis (QuickSet TKP)
Eyekon Medical, Inc.
SkyOPS Orthopedic Plate System
Sky Surgical, LLC
Exceed Biplanar Expandable Interbody System
Spine Wave, Inc.
BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes
Becton, Dickinson and Company
Equinoxe® Scapula Fracture System
Exactech, Inc.
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
Medtronic Sofamor Danek USA, Inc.
PRIMED Surgical and Procedure Masks
Primed Medical Products, Inc.
ProLift Pivot Expandable Spacer System
Life Spine, Inc.
MiPACS HTML5 Web Viewer
Lead Technologies, Inc.
Urocross Expander System (Model Numbers ES2018 and ES3025)
Prodeon Medical, Inc.
3 Ply Medical Grade Single Use Procedural Disposable Face Mask
Kdi Med Supply
DASH® SARS-CoV-2 & Flu A/B Test
Nuclein, LLC
Neodent Implant System-Helix NGM Compact Surgical Kit Cases
JJGC Indústria e Comércio de Materiais Dentários S.A.
ELISIO-H
Nipro Medical Corporation
Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation
Biotronik, Inc.
CT 5300
Philips Healthcare (Suzhou) Co., Ltd.
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
Nobel Biocare AB
NaviCam ProScan
Ankon Technologies Co., Ltd.
Medline UNITE® MIS Foot Recon Screw System
Medline Industries, LP
Cue COVID-19 Molecular Test
Cue Health, Inc.
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