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
SignalHF (IM008)
Implicity, Inc.
da Vinci Surgical System (IS5000)
Intuitive Surgical, Inc.
NeuroTrigger Basic (NTB)
Neurotrigger
Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint
Conformis, Inc.
Segment 3DPrint
Medviso AB
FUBUKI XF Neurovascular Long Sheath
Asahi Intecc Co., Ltd.
NorthStar Mapping System
Imricor Medical Systems
T2Candida 1.1 Panel
T2biosystems, Inc.
NEXXT SPINE NAVIGATION System
Nexxt Spine, LLC
LUMYS (V1)
Intradys
iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
Ihealth Labs, Inc.
Dermalage
Infection Elimination Solutions, LLC
APPRAISE-HRI
The Surgeon General, Department of the Army (TSG-DA)
EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
Etex Corporation
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
Guangzhou Xinbo Electronic Co., Ltd.
Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System
Alphatec Spine, Inc.
CATALYSTEM Femoral Stems
Smith & Nephew, Inc.
FemChec Controlled Saline-Air Device (FCD-250)
Femasys, Inc.
SPECTRA Wearable 2
Uzinmedicare Co., Ltd.
CN-Suite
FIND Surgical Sciences Inc. D/B/A FIND Neuro
Tamburo Thulium Fiber Laser System
Menovex Medical Technology (Shenzhen) Co., Ltd.
Brain Anesthesia Response Monitor (Bar Monitor)
Cortical Dynamics , Ltd.
Synthetic Bone Putty
Ventris Medical
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
Abbott Diabetes Care, Inc.
Treace Medical Concepts (TMC) Compression Implant System
Treace Medical Concepts
Cryo 7
Zimmer Medizinsysteme GmbH
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-
FloShield, Inc.
Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard
Co-Innovation Biotech Co., Ltd.
EMPHASYS Acetabular System
Depuy Ireland UC
Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar
Taiwan Surgical Corporation
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