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
V-soft Line Barbed Surgical Suture (Various)
Feeltech Co., Ltd.
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH
Remington Medical, Inc.
Protrieve Sheath
Inari Medical, Inc.
Gastric Alimetry System
Alimetry , Ltd.
Bone Anchor (NGS-BA-01)
ClearPoint Neuro, Inc.
Bioscope Neuromonitor Device
Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
eRAD PACS
Erad, Inc.
Q21
Neurofield, Inc.
Primum Hydrophilic Guiding Catheter
Pendracare
Leaderflex Mini and Leaderflex Nano
Vygon USA
DeltaNEC Interbody System
Nexus Spine
Argus Cognitive ReVISION Software
Argus Cognitive, Inc.
Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (
Speciality Fibres and Materials Limited
Arthrx Fracture Plates
Arthrex, Inc.
MultiPulse HoPLUS
Asclepion Laser Technologies GmbH
CM005 Standard (CM005); CM004 Mini (CM004)
Connexicon Medical , Ltd.
AI-Rad Companion Organs RT
Siemens Medical Solutions U.S.A.
Bakri Essential Postpartum Balloon
Cook Incorporated
Benchmark BMX96 Access System
Penumbra, Inc.
Aura Wave
Aura Wellness, LLC
Power wheelchair (N6101)
Zhejiang Zhonglei Medical Technology Co. , Ltd.
Ear Pressure Relief Device(Model:ER813B)
Ningbo Albert Novosino Co., Ltd.
RadioLens v1.0
Synapsica
Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
Coagusense, Inc.
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equ
Physio-Control, Inc.
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Unimed Medical Supplies, Inc.
Intense Pulsed Light Treatment System (LK-PT)
Nanjing Bestview Laser S&T Co., Ltd.
Portable Folding Electric Wheelchair (Model: DC01)
Anhui Jbh Medical Apparatus Co., Ltd.
Grappler Suture Anchor System
Paragon 28, Inc.
Contour ProtegeAI
Mim Software, Inc.
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