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
Oclet TDS 1000
Tendonova Corporation
Sterile Silver Alginate Wound Dressing
Qingdao Bright Moon Biomedical Materials Co., Ltd.
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F)
Bright Uro, Inc.
Dental Cone-beam Computed Tomography
Yian Medical Technology (Haining) Co., Ltd.
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical Ltd. Dba Surmodics, Inc.
RejuvaKnee Collagen Meniscus Implant
Collagen Matrix, Inc.
Elecsys Phospho-Tau (181P) Plasma
Roche Diagnostics
Venus BlissMAX
Venus Concept USA, Inc.
Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (
Genadyne Biotechnologies, Inc.
OsteoPlan System
Osteomed, LLC
Medical Surgical Mask (Model: JM92, JM92B)
Guangdong Jia Mei Biological Technology Co.Ltd
EarliPoint System
Earlitec Diagnostics
SAFIRA
Medovate Limited
Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (32
Nuwellis, Inc.
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
3M Company, Unitek Orthodontic Products
Device 300397 Putty
Geistlich Pharma AG
ViewFlex Xtra Reprocessed ICE Catheter
ABBOTT MEDICAL
Cemented Plus Abutment
Unidental Co., Ltd.
Helios Dura Regeneration Matrix
Helios Biomedical, Inc.
Snorbliss® Anti-Snoring Device
Endeavor Commerce, LLC
Tyto Insights for Eardrum Bulging Detection
Tyto Care , Ltd.
Obsidian® Press Over Zirconia
Prismatik Dentalcraft, Inc.
Calcium2
Abbott Ireland
Bluemoon
Genoss Co., Ltd.
CanGaroo RM Antibacterial Envelope
Elutia, Inc.
Electric Wheelchair (HBLD3-B); Electric Wheelchair (HBLD3-E)
Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
Solco Biomedical Company India Private Limited
Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
Hubei Yjt Technology Co.,Ltd
Stanza
Swing Therapeutics, Inc.
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
Ortho Clinical Diagnostics
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