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
Gemini Sterilization Wrap
Medline Industries, LP
TCL3 Motion Tracking System
Tracinnovations A/S
ANNE Sleep
Sibel, Inc.
LED Light Therapy Device, ELIXIR MD
Yassen Wellness, LLC
Digital Video Processor
Hunan Vathin Medical Instrument Co., Ltd.
Over-tube (TR-1108A)
Fujifilm Corporation
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test
Eterbio, Inc.
Synq Software Version 1.3
Synaptive Medical, Inc.
IntelliVue Patient monitors MX400, MX450, MX500, MX550
Philips Medizin Systeme Boeblingen GmbH
NeoBeat, NeoBeat Mini
Laerdal Medical AS
Dukal Crepe Paper Sterilization Wrap
Dukal, LLC
DORA Disposable A.V. Fistula Needle Sets
Bain Medical Equipment (Guangzhou) Co., Ltd.
BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)
Becton, Dickinson and Company
SKR 3000
Konica Minolta, Inc.
multiFlux 130 (F00013123); multiFlux 160 (F00013124)
Fresenius Medical Care Renal Therapies Group, LLC
Full Wedge Lateralized and Augmented Baseplates
Fx Shoulder USA, Inc.
Porous Patella and Porous Tibia Baseplate
Smith & Nephew, Inc.
LUDWIG Electrosurgical Device
Aesthetics Biomedical
Ennovate Cervical Spinal and Occiput System
Aesculap Implant Systems, LLC
NPseal (Small, Medium, Large)
Guard Medical, Inc.
HyperSuture All Green Extension Line
Threadstone, LLC
Therapy US
Dmc Importação E Exportação DE Equipamentos Ltda
Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter
Applied Medical Resources Corporation
R:GEN
Lutronic Vision, Inc.
Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro)
Beijing Konted Medical Technology Co.,Ltd
LZI Fentanyl III Enzyme Immunoassay
Lin-Zhi International, Inc.
Ear Thermometer, Model ET001
Guangzhou Berrcom Medical Device Co., Ltd.
Mico One Orthodontic Screw
Ze Fang Technology Co., Ltd.
S.E.A.L. Hemostatic Wound Spray
Bc3 Technologies, Inc.
TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant
Church & Dwight Co., Inc.
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