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
Lifemotion Disposable Membrane Oxygenator
Lifemotion Medical Technology Co., Ltd.
MI View&GO
Siemens Medical Solutions USA, Inc.
ToxiSeal Vial Adaptor with External Flip Balloon
Epic Medical Pte. , Ltd.
Genius AI Detection 2.0
Hologic, Inc.
Pro-Tx Endorectal Balloon (PROT-25)
Dxtx Medical, Inc.
Precice Intramedullary Limb Lengthening System
Nuvasive Specialized Orthopedics, Inc.
Chartis Precision Catheter
Pulmonx Corporation
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series T
Covidien
AirTom
Bilab
Kangbeier Child Surgical Mask
Xinxiang Kangbeier Medical Technology Co., Ltd.
XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conv
Stryker Spine
VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P
Vinno Technology (Suzhou) Co.,Ltd
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Rmkh Glove (Cambodia) Co., Ltd.
BriefCase-Quantification
Aidoc Medical , Ltd.
Varios Combi Pro2
Nakanishi, Inc.
Diosculpt
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Myflon Surgical Mask Level 3
Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi
GMReis Suture Anchors
GM Dos Reis Industria e Comercio Ltda.
CORTRAK* 2 Enteral Access System (20-0950)
Avanos Medical, Inc.
Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle
Sol-Millennium Medical, Inc.
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Con
Pegavision Corporation
MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA, Inc.
Contour ProtégéAI
Mim Software, Inc.
Radiant Renewal Skincare Wand (HD-15, HD-15A)
Shenzhen Kaiyan Medical Equipment Co., Ltd.
JDZygoma dental implants
Jdentalcare Srl
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microte
Microtek Medical, LLC
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
The Magstim Company Limited
ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (EC3D60S); ECHELON 4000 60mm Long Staple
Ethicon Endo-Surgery, LLC
VersaWrap
Alafair Biosciences, Inc.
AI Segmentation
Varian Medical Systems, Inc.
Track 510(k) device clearances
Get notified when new devices are cleared in your category.
Set Up Free Alert