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
Brain WMH
Quantib B.V.
cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE M
AtriCure, Inc.
KLS Martin IPS Forearm System
KLS-Martin L.P.
PLANET Onco Dose (3.2)
Dosisoft SA
QOCA® image Smart RT Contouring System
Quanta Computer, Inc.
Simple 2 Test
Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.)
APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System
Apollo Endosurgery, Inc.
Gemini Cervical Fusion Cage System
ZheJiang Decans Medical Devices Co., Ltd.
Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
Largan Medical Co., Ltd.
CD Horizon Spinal System
Medtronic Sofamor Danek USA, Inc.
Disposable Laparoscopic Trocar
Changzhou Ankang Medical Instruments Co., Ltd.
Rio Drug Reconstitution Transfer Device
Icu Medical, Inc.
EzSensor HD
Qpix Solutions, Inc.
Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen®
Healgen Scientific,, LLC
AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers
STERIS Corporation
TroClose 1200
Gordian Surgical, Ltd.
DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal
Alcon Laboratories, Inc.
Additive Manufacturing (Light Curing) Crown Bridge Resin
Aidite (Qinhuangdao) Technology Co., Ltd.
twiist Automated Insulin Delivery (AID) System
Deka Research and Development
Nitrile Examination Gloves
Anhui Fine Glove Medical Technology Co., Ltd.
V-Print dentbase
Voco GmbH
Polaris X Unidirectional Steerable Diagnostic Catheter
Boston Scientific Corporation
CEPHX- Cephalometric Analysis Software
Orca Dental AI , Ltd.
Houdini Cross Support Catheter
Cruzar Medsystems, Inc.
Nanox.ARC X
Nano-X Imaging , Ltd.
NeuroRPM
New Touch Digital, Inc.
KHEIRON® Spinal Fixation System, including patient specific K-ROD
S.M.A.I.O
Terumo Injection Filter Needle (NF-3013RBKE05M)
Terumo Europe N.V.
Salto Talaris Ankle PSI System
3D Systems, Inc.
Endo Ultrasonic Activator
Foshan Coxo Medical Instrument Co., Ltd.
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