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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 (0.0156–4 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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