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
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid
Depuy Ireland UC
Eleganz IM Threaded Nail System (IM Threaded Nail System)
Dev4
Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
Enpuno Biotechnology Co., Ltd.
BD PowerPiCC Catheter
Bard Access Systems, Inc.
VSP Bolus
3D Systems
Celerity Chemical Indicator for enspire 3000 CLCSPS
STERIS Corporation
PASS LP Spinal System, CD Horizon Spinal System
Medicrea International SA
cvi42 Auto Imaging Software Application
Circle Cardiovascular Imaging, Inc.
SmartClip Secure Soft Tissue Marker
Elucent Medical, Inc.
TroClose 1200
Gordian Surgical, Ltd.
LORRAINE 2.5/3.5mm Distal Humerus System
Bonebridge AG
LifeShield Infusion Safety Software Suite
Icu Medical, Inc.
TRUST
Rgorithm Korea
SM-IV
Sedecal., Sa.
Tandem Mobi Insulin Pump with Interoperable Technology
Tandem Diabetes Care, Inc.
HYDROS Robotic System (HY1000); HYDROS Handpiece (HH1000); HYDROS TRUS Probe (HU1000)
Procept Biorobotics
Sleep Apnea Feature
Samsung Electronics Co., Ltd.
Medical Diode Laser (M2)
Wuhan Pioon Technology Co., Ltd.
AVAVA Skin Treatment System
AVAVA, Inc.
XSTAT 30 Pouch
Revmedx, Inc.
Prophecy Surgical Planning System
Wright Medical Technology, Inc. (Stryker)
Disposable Nitrile Medical Powder-free Glove
Fujian Chunhui Medical Supply Co., Ltd.
SmartGuard technology; Predictive Low Glucose technology
Medtronic Minimed, Inc.
Platform® Acetabular System
Total Joint Orthopedics, Inc.
BALTEUM - ONE Lumbar Plate System
Huvexel Co. , Ltd.
VITEK 2 AST-Gram Positive Cefoxitin Screen
bioMerieux, Inc.
Jet Flow Bulk
Meta Biomed Co., Ltd.
Gastric Alimetry
Alimetry , Ltd.
Baby Gorilla/Gorilla Plating System
Paragon 28, Inc.
EUROPA Navigated Instruments
MiRus, LLC
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