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
Rhinolaryngoscope system
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Neteera 130H/131H Vital Sign Monitoring Sensor
Neteera Technologies , Ltd.
Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M)
Quara S.R.L.
Flexible Partial Resin
Prismatik Dentalcraft, Inc.
The Integrity Spine Core System
Integrity Spine
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Ser
Unimed Medical Supplies, Inc.
10HQ701G-B
Lg Electronics.Inc
Intracept Intraosseous Nerve Ablation System
Relievant Medsystems, Inc.
Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System
Zoll Circulation, Inc.
RipCord
TriMed, Inc.
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
Leone S.P.A.
GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)
Geneseeq Technology, Inc.
Hemo-Lyte C Cartridge
Di-Chem, Inc.
NEW DOUBLO 2.0
Hironic Co., Ltd.
Swedge Pedicle Screw Fixation System Bezier Rod
Spinal Resources, Inc.
Cold Compression Wrap Pro
Chengdu Cryo-Push Medical Technology Co.,Ltd
da Vinci Firefly Imaging System
Intuitive Surgical, Inc.
RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTI
Xenix Medical
OR3O Dual Mobility Liners
Smith & Nephew, Inc.
MSKai
Mskai
Otsuka Digital Feedback Device
Otsuka America Pharmaceutical, Inc.
F88 URE-SD/RD Flexible Ureteroscope
Sg Endoscopy Pte, Ltd.
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
Suzhou Minhua Medical Apparatus Supplies Co., Ltd.
da Vinci Surgical System, IS5000
Intuitive Surgical, Inc.
PERLA® TL Posterior Osteosynthesis System
Spineart
Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
Dci International, LLC
Accure Laser
Accure Acne, Inc.
FRAXION Spinal Fixation System
Ortler Global Tibbi Gerecler Anonim Sirketi
WATCHMAN TruSteer Access System (M635TU90050)
Boston Scientific Corporation
Profoject Safety Sliding Blood Collection Set
CMT Health PTE., Ltd.
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