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
Ion Endoluminal System (IF1000)
Intuitive Surgical, Inc.
ZeroClear Bag Access (423100)
Epic Medical Pte. , Ltd.
Alinity h-series System
Abbott Laboratories
Second Opinion® 3D
Pearl, Inc.
70 NeuGlide Catheter
Piraeus Medical, Inc.
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
Caf Medical Solutions, Inc.
Fibresolve
Imvaria, Inc.
BioPoly Radial Head Implant
BioPoly, LLC
eMotus Respiratory Motion Management System
Empnia, Inc.
Temperature Sensor Probe (ABL-18TP20)
Varian Medical Systems, Inc.
Auryon Atherectomy System
Eximo Medical, Ltd.
Zyter RPM
Zyter, Inc.
Venus BlissMAX
Venus Concept USA, Inc.
OSSIOfiber® Threaded Trimmable Fixation Nail
OSSIO , Ltd.
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Fitone Latex Products Co., Ltd. Guangdong
3 Layer Surgical Mask (134252531)
Original Mattress Factory, Inc.
CastleLoc-P Anterior Cervical Plate System
L&K BIOMED Co., Ltd.
Orthopeasia Spinal Fixation System
Orthopeasia Co., Ltd.
Happy Health Home Sleep Test
Happy Health, Inc.
SleepCheckRx
Resapp Health
Point implant system
Pointnix Co., Ltd.
Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 65cm Maceration Wire,
Argon Medical Devices, Inc.
Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection); Ambu® aBox 2
Ambu A/S
NOxBOXi Nitric Oxide Delivery System
Linde Gas & Equipment, Inc.
Bifix Hybrid Abutment Cement
Voco GmbH
TITAN Nail; APTUS K-Wire System
Medartis AG
Xpert C. difficile/Epi
Cepheid®
Proximerge 2 Dental Implant System
Quadric Biomed, LLC
LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
Dongguan Boyuan Intelligent Technology Co.,Ltd
Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories
Stryker Leibinger GmbH & Co KG
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert