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
DEKA Infusion System, DEKA Administration Set
Deka Research and Development
LumiGlam Laser System (SHE-LSP601-3)
Beijing Sano Laser S&T Development Co.,Ltd
Companion Spine DIAM Instrumentation
Companion Spine France
Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System
Maquet Cardiovascular, LLC
Surgical Gown
Wujiang Tutaike Textiles & Finishing Co., Ltd.
SkyOPS Orthopedic Plate System
Sky Surgical, LLC
ProLift Pivot Expandable Spacer System
Life Spine, Inc.
VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System
Stryker GmbH
da Vinci Surgical System, IS5000
Intuitive Surgical, Inc.
OK Plus Indicator
Propper Manufacturing Co., Inc.
AirLife DuoTherm Humidification System
Vyaire Medical, Inc.
VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)
Olympus Medical Systems Corporation
Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
Qingdao Kingon Medical Science and Technology Co., Ltd.
Highness Implant System
Highness Co., Ltd.
ARIX Femur Nail System
Jeil Medical Corporation
VersaWrap
Alafair Biosciences, Inc.
Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
Promisemed Hangzhou Meditech Co., Ltd.
Exofin Precision Pen
Chemence Medical, Inc.
ARK Levetiracetam II Assay
Ark Diagnostics, Inc.
OtoSight Middle Ear Scope
Photonicare, Inc.
Pantheon Proximal Femur Reconstruction (PFR) System
Adler Ortho S.P.A
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope
Nidek Co., Ltd.
BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets
Becton, Dickinson and Company
SPY Laparoscope
Stryker
XN Knee Prosthesis System
Beijing Chunlizhengda Medical Instruments Co., Ltd.
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software 2050
Murata Vios, Inc.
3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG)
3M Healthcare Business Group
BD Vacutainer® Eclipse Blood Collection Needle
Becton, Dickinson and Company
PYXIS 3D Titanium Cervical Cage system
GS Medical Co., Ltd.
LOTUS Series 4 Enhanced Shears, LOTUS Series 5
Sra Developments, Ltd.
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