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
Fetal EchoScan
Brightheart
uLab Systems Dental Aligner Kit
Ulab Systems, Inc.
CAS-One IR
Cascination AG
Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB
Joytech Healthcare Co. , Ltd.
Medical diode laser systems (CHARISMA, REGAL)
Reveal Lasers , Ltd.
ECMT-100 WMD
Ecm Therapeutics, Inc.
LYNX COBLATION Laryngeal Wand (72290254)
ArthroCare Corporation
Vulcan Spinal System
K2m, Inc.
ZSFab Lumbar Interbody System
Zsfab, Inc.
Medicon Epiplating System
Cmf Medicon Surgical, Inc.
Triathlon Pro
Sigma Biomedical
Bio Fluff System
Gnali Bocia S.R.L.
Ablation-fit
R.A.W. S.R.L
Lumify Diagnostic Ultrasound System
Philips Ultrasound, LLC
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vita
Jk-Holding GmbH
CentriMag Blood Pump for use with CentriMag Acute Circulatory Support System
Abbott (Formerly Thoratec Corporation)
Philips IntelliSite Pathology Solution 5.1
Philips Medical Systems Nederland B.V.
Genius AI Detection 2.0
Hologic, Inc.
ERI Handheld Dental X-ray System (Model AG100)
Energy Resources International Co., Ltd. Hsinchu Branch
Sterile Syringes for Single Use
Shanghai Kindly Enterprise Development Group Co., Ltd.
Endo Motor
Shenzhen Perfect Medical Instruments Co., Ltd.
DTX Studio Clinic (4.0)
Nobel Biocare AB
CMN Capillary Function with Oncology Virtual Expert
Cercare Medical A/S
Unscented Menstrual Tampon
Suzhou Borage Medical Technology Co., Ltd.
Medcare Powder-Free Blue Nitrile Patient Examination Gloves
Dongguan Grinvald Technology Co., Ltd.
ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
1987 Media Limited
RAYDENT SW
Ray Co., Ltd.
Omni Legend
Ge Medical Systems Israel, Functional Imaging
AXS Lift Intracranial Base Catheter
Stryker Neurovascular
HPR45i
F Care Systems USA, LLC
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