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
8089–8112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 16, 2024
Disposable safety lancet (Impress)
K233796 · FMK
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 48d
Cleared Jan 16, 2024
Rapid (6.0)
K233512 · QIH
Ischemaview, Inc.
Radiology · 76d
Cleared Jan 16, 2024
Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
K233293 · QGL
Neurosigma, Inc.
Neurology · 109d
Cleared Jan 16, 2024
Non absorbable Surgical Silk Suture
K232355 · GAP
Shandong Haidike Medical Product Co.,...
General & Plastic Surgery · 162d
Cleared Jan 16, 2024
Uni-port
K232062 · OTJ
Dalim Medical Corp.
General & Plastic Surgery · 189d
Cleared Jan 16, 2024
Washtrays
K231144 · KCT
Dentsply Sirona
General Hospital · 270d
Cleared Jan 16, 2024
Aniti-Snore Mouthguard+
K231138 · LRK
Oscimed SA
Dental · 270d
Cleared Jan 16, 2024
Hilzo Esophageal Stents
K223266 · ESW
Thoracent, Inc.
Gastroenterology & Urology · 449d
Cleared Jan 16, 2024
Delta4 Insight
K223234 · IYE
Scandidos AB
Radiology · 454d
Cleared Jan 13, 2024
CLEWICU System
K233216 · QNL
Clew Medical , Ltd.
Cardiovascular · 107d
Cleared Jan 13, 2024
Stryker Facial iD System
K232350 · JEY
Stryker Craniomaxillofacial
Dental · 159d
Cleared Jan 12, 2024
GI Genius™ Module 100 (GGM100.US)
K233964 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 28d
Cleared Jan 12, 2024
Meridian Interbody System
K233694 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 56d
Cleared Jan 12, 2024
Biograph VK10
K233677 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Jan 12, 2024
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use...
K233520 · LZA
Anhui Powerguard Technology Co., Ltd.
General Hospital · 72d
Cleared Jan 12, 2024
Cypris eXact Suturing System
K233355 · GAW
Cypris Medical
General & Plastic Surgery · 105d
Cleared Jan 12, 2024
ClearPointer Optical Navigation Wand
K233155 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
ClearPoint Bone Screw Fiducials
K233144 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
SmartFrame OR
K233141 · HAW
ClearPoint Neuro, Inc.
Neurology · 107d
Cleared Jan 12, 2024
Zirconia Block
K233125 · EIH
Hangzhou Ivista Medical Devices Co.,...
Dental · 107d
Cleared Jan 12, 2024
LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
K233114 · OHS
Shenzhen Idea Light Limited
General & Plastic Surgery · 107d
Cleared Jan 12, 2024
Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask...
K233022 · MSH
Owens & Minor (O&M) Halyard, Inc.
General Hospital · 112d
Cleared Jan 12, 2024
TauTona Pneumoperitoneum Assist Device (TPAD)
K233020 · HIF
Tautona Group Research & Development,...
Obstetrics & Gynecology · 112d
Cleared Jan 12, 2024
A’TOMIC™ Nitinol Fixation System
K232990 · JDR
Rmr Ortho, LLC
Orthopedic · 112d