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
LaproGlide Disposable Monopolar PTFE Coated Laparoscopic Probes
Surgical Principals, Inc.
CINA-ASPECTS
Avicenna.Ai
Embozene Color-Advanced Microspheres
Varian Medical Systems, Inc.
DD medical polymers (PMMA)
Dental Direkt GmbH
CAIs Sensor (CAIs-001)
Brainu Co., Ltd.
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Elekta Solutions AB
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Gentuity, LLC
Disposable Insulin Pen Needle
Hantech Medical Device Co., Ltd.
0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP Syringe
Becton, Dickinson and Company
3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
3M Company
Dental porcelain powder
Yilink (Tianjin) Biotechnology Co., Ltd.
LimFlow V-Ceiver
LimFlow, Inc.
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imip
Thermo Fisher Scientific
FX CorAL 40; FX CorAL 50
Fresenius Medical Care Renal Therapies Group, LLC
CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES
Medicon Hellas S.A
T-FIX® 3DSI Joint Fusion System
Cutting Edge Spine, LLC
TENS device-EmeTerm 2, Model: YF-ZTY-E2
Wat Medical Technology, Inc.
Applied Biosystems TaqPath COVID-19, Flu A, Flu B, RSV Select Panel
Life Technologies Corporation
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
Boston Scientific Corporation
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay
Diazyme Laboratories, Inc.
Versius Surgical System (Versius Plus)
Cmr Surgical Limited
SkinStylus SteriLock MicroSystem (MP1209SL)
Esthetic Medical, Inc.
Microdent Sterilization Cassette
Implant Microdent System S.L.U.
SIGNA MAGNUS
Ge Medical Systems, LLC
BIB Stent Placement Catheter
NuMED, Inc.
Family of Venus RF Systems - Venus Freedom
Venus Concept USA, Inc.
Silk'n Titan Allways
Silk'N Beauty , Ltd.
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Unimed Medical Supplies, Inc.
EnSite X EP System
ABBOTT MEDICAL
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
Shenzhen Ulike Smart Electronics Co., Ltd.
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