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
Elecsys AMH
Roche Diagnostics
Eclipse Treatment Planning System (18.1)
Varian Medical Systems
EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic Closed System Intermittent Catheter K
HR Healthcare
Firebird SI Navigation System
Orthofix US, LLC
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
Univlabs Technologies Private Limited
Paragon 28 External Ring Fixation System
Paragon 28, Inc.
MOTOTM Partial Knee & MOTO PFJ Systems Extension
Medacta International S.A.
Sterile hypodermic syringes for single use
Jiangsu Kangyou Medical Instrument Co., Ltd.
Novum IQ Syringe Pump (40800BAXUS)
Baxter Healthcare Corporation
Medical Protective Masks
Qinhuangdao Taizhi Medical Technology Co., Ltd.
SCOUT MD Surgical Guidance System
Merit Medical Systems, Inc.
Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)
Shenzhen AOJ Medical Technology Co., Ltd.
Vial Adapter 20mm
West Pharma. Services IL, Ltd.
Syngo Carbon Clinicals (VA41)
Siemens Healthineers AG
Protective Gown AAMI Level 4
Kenpax International Limited
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Unicon Optical Co., Ltd.
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster®
Biosense Webster, Inc.
Aquilion ONE (TSX-308A/TSX-306A) V2.0
Canon Medical Systems Corporation
DCwire Micro-guidewire
Shanghai Achieva Medical Suzhou Co., Ltd.
Removal System Large Bore 60 cc Syringe
Inari Medical, Inc.
Canady Flex RoboWrist
Us Medical Innovations, LLC
DeepRhythm Platform
Medicalgorithmics S.A.
Geon (S2) Nasal Aspirator
Geon Corporation
Senhance Surgical System
Asensus Surgical, Inc.
Cadwell Guardian
Cadwell Industries, Inc.
SNUCONE Bone Level Implant System
Snucone Co., Ltd.
Power wheelchair
Zhejiang Zhonglei Medical Technology Co. , Ltd.
GMK Sphere & GMK SpheriKA Cementless
Medacta International S.A.
BAHADIR STERILIZATION CONTAINERS
Bahadir USA, LLC
Anti Snore Mouthpiece
Dongguan Yiyao Science & Technology Development Co., Ltd.
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