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
Us2.ca
Eko.Ai Pte Ltd. D/B/A Us2.Ai
Tigon Medical All-Suture Anchors (ASA)
Tigon Medical
Oxiplex®
Fziomed, Inc.
XChange Device, XChange System
Pneuma Therapeutics, Inc.
SIS System
Surgical Information Sciences, Inc.
Identity Shoulder System
Zimmer, Inc.
SGM Femoral Nail System
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.
Arthrex LoopLoc Knotless Suture
Arthrex, Inc.
StealthFix Intraosseous Fixation System
Nextremity Solutions, Inc.
Enteral Syringe (20ml, 60ml)
Chirana T.Injecta,A.S.
NEOVEIL Staple Line Reinforcement
Gunze Limited
UniVit HE, UniVit UHS
Visioncare Devices, LLC
Tandem Mobi insulin pump with interoperable technology
Tandem Diabetes Care, Inc.
Branchor X Balloon Guide Catheter
Asahi Intecc Co., Ltd.
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
Olympus Medical Systems Corporation
Vial Adapter 20mm
West Pharma. Services IL, Ltd.
BD Veritor System for SARS-CoV-2
Becton, Dickinson and Company
Disposable Surgical Gown
Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
Orthocell, Ltd.
SmartGuard Technology; Predictive Low Glucose Technology
Medtronic MiniMed
BD Surgiphor Antimicrobial Irrigation System
Bd
Luminice
Premier North America, Inc.
Benesta Tissue Removal Device
Caldera Medical, Inc.
Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpi
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
OsteoSinter® EVANS and COTTON wedges and related accessories
Ames Medical Prosthetic Solutions, S.A.U.
Tissue Approximation System (TAS)
Tas Medical, Inc.
REAL INTELLIGENCE CORI (CORI)
Blue Belt Technologies, Inc.
BreathID Hp Lab System, BreathID Smart System
Meridian Bioscience Israel , Ltd.
Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)
Philips Medizin Systeme
IPL sapphire ice cooling hair remove device
Shenzhen Desida Technology Co., Ltd.
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