FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
8401–8424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2023
iFlash-HCG
K223690 · DHA
Shenzhen Yhlo Biotech Co., Ltd.
Chemistry · 367d
Cleared Dec 11, 2023
EDS Calculus Softener TURBO CR
K223340 · ELC
Essential Dental Systems, Inc.
Dental · 405d
Cleared Dec 08, 2023
VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical...
K233654 · JOJ
Steris
General Hospital · 24d
Cleared Dec 08, 2023
10F Sheath and Dilator Set
K233432 · DYB
Argon Medical Devices, Inc.
Cardiovascular · 57d
Cleared Dec 08, 2023
Global Modular Replacement System
K233261 · JDI
Howmedica Osteonics Corp. A.K.A....
Orthopedic · 70d
Cleared Dec 08, 2023
Vibrant System
K232830 · QTN
Vibrant, Ltd.
Gastroenterology & Urology · 86d
Cleared Dec 08, 2023
BTI Interna Prosthetic Components
K232750 · NHA
B.T.I. Biotechnology Institute, Sl.
Dental · 91d
Cleared Dec 08, 2023
PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port
K232737 · LJT
Bard Peripheral Vascular, Inc.
General Hospital · 92d
Cleared Dec 08, 2023
Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302,...
K232517 · NUH
Shenzhen Kentro Medical Electronics...
Neurology · 112d
Cleared Dec 08, 2023
Valkyrie Thoracic Fixation System
K232515 · HRS
Jm Longyear Manufacturing, LLC D.B.A....
Orthopedic · 112d
Cleared Dec 08, 2023
DVAS (DVAS-M, DVAS-W)
K232085 · EHD
Genoray Co., Ltd.
Radiology · 148d
Cleared Dec 08, 2023
SimpleSense-BP, SimpleSense-BP Software Application
K232053 · DXN
Nanowear, Inc.
Cardiovascular · 150d
Cleared Dec 08, 2023
Novii+ Wireless Patch System
K231964 · HGM
Datex-Ohmeda
Obstetrics & Gynecology · 158d
Cleared Dec 08, 2023
DTX Studio Clinic (4.0)
K231898 · LLZ
Nobel Biocare AB
Radiology · 163d
Cleared Dec 08, 2023
F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and...
K231743 · MAX
Corelink, LLC
Orthopedic · 177d
Cleared Dec 08, 2023
NeuroBlate System
K231061 · GEX
Monteris Medical,
Neurology · 239d
Cleared Dec 08, 2023
Eagle device
K230722 · HQF
Belkin Vision, Ltd.
Ophthalmic · 267d
Cleared Dec 08, 2023
Bonelogic
K223757 · QIH
Disior, Ltd.
Radiology · 358d
Cleared Dec 08, 2023
Lumina-PTFE Titanium
K221851 · NPK
Criteria Industria E Comercio DE...
Dental · 529d
Cleared Dec 07, 2023
OTS 25 (100-1)
K233429 · MBI
Ots Medical , Ltd.
Orthopedic · 57d
Cleared Dec 07, 2023
Light Based Hair Removal Device
K232846 · OHT
Shenzhen Meik Beauty Industry Co., Ltd.
General & Plastic Surgery · 84d
Cleared Dec 07, 2023
Led Mask Platinum Exclusive MD
K232795 · OHS
Stg24 Co., Ltd.
General & Plastic Surgery · 86d
Cleared Dec 07, 2023
ProNephro AKI™ (NGAL)
K232761 · PIG
Bioporto Diagnostic, Inc.
Chemistry · 90d
Cleared Dec 07, 2023
Myocardial Strain Software Application
K232661 · LLZ
Circle Cardiovascular Imaging
Radiology · 98d