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
Ultra RapidWarm Blast
Vitrolife Sweden AB
Capsule Vitals Plus Patient Monitoring System
Capsule Technologie Sas
Portable Scalp Cooling System
Cooler Heads Care, Inc.
X-Guide® Surgical Navigation System
X-Nav Technologies, LLC
SafeR Syringe and SafeR Sting
Roncadelle Operations Srl
Pulse Oximeter
Beijing Choice Electronic Technology Co., Ltd.
Kurin Blood Culture Collection Set with Kurin Lock Technology
Kurin, Inc.
Grappler Interference Screw System
Paragon 28, Inc.
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Hindernis DE Mexico, S.A.P.I. DE C.V.
Articulator Arthroscopic Bur
Joint Preservation Innovations, LLC
GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
Zhuhai Fitlens Medical Technology Co., Ltd.
BriefCase
Aidoc Medical , Ltd.
Power wheelchair
Zhejiang Zhonglei Medical Technology Co. , Ltd.
OSSIOfiber® Interference Screw
OSSIO , Ltd.
Aptiva CTD Essential Reagent
Inova Diagnostics, Inc.
NS-HGlio
Neosoma, Inc.
AnemoCheck Home
Sanguina, Inc.
Glidewell Appliance Resin, Hard/Soft
Prismatik Dentalcraft, Inc.
Toro-L Interbody Fusion System
Integrity Implants, Inc.
AdVance XP Male Sling System (720163-03)
Boston Scientific Corporation
syngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
inspired VHB20 Heated Humidifier
Vincent Healthcare Products Limited
PainShield MD PLUS
Nanovibronix, Inc.
LungQ v3.0.0
Thirona BV
Quantra QStat Cartridge
Hemosonics, LLC
BASE290 LED Curing Light
Handpiece Headquarters
Disposable Brain Biopsy Needle 2.0
PAJUNK GmbH Medizintechnologie
Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code AC
Trax Surgical
Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018)
Taiwan Aulisa Medical Devices Technologies, Inc.
Steriking® LT-Blueline Pouches with Tyvek®
Wipak OY
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