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: 2026–2026 ×
1,922 results
577–600 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Jun 02, 2026
MILAN System
K253803 · GEI
Lumenis Be, Ltd.
General & Plastic Surgery · 186d
Cleared Jun 02, 2026
Packaged Assembly, Reusable Navigation Unit
K253507 · ONN
Orthalign, Inc.
Orthopedic · 211d
Cleared Jun 02, 2026
Hemospray Endoscopic Hemostat (HEMO-[X])
K253302 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 246d
Cleared Jun 02, 2026
TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
K253195 · NKG
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 249d
Cleared Jun 02, 2026
Female Culture Device
K252899 · JKA
Zhejiang Kindly Medical Device Co., Ltd.
General Hospital · 264d
Cleared Jun 02, 2026
Tyto Insights for Wheeze Detection (with PCCP)
K252844 · PHZ
Tyto Care , Ltd.
Anesthesiology · 267d
Cleared Jun 02, 2026
High Tone Power therapy (HiToP) (Model: HiToP PNP)
K252816 · IPF
Mohammadali Nezakati
Neurology · 271d
Cleared Jun 02, 2026
Inno-Port Disposable Bladed Trocar
K252532 · GCJ
Taiwan Surgical Corporation
General & Plastic Surgery · 294d
Cleared Jun 01, 2026
VisionAir Enhanced Stock Stent
K261541 · NWA
VisionAir Solutions
Anesthesiology · 24d
Cleared Jun 01, 2026
VI°Port™ Liver Preservation System
K260456 · KDN
Traferox Technologies, Inc.
Gastroenterology & Urology · 110d
Cleared Jun 01, 2026
CorDx Tyfast COVID-19 Ag Rapid Test Rx
K253882 · QVF
CorDx, Inc.
Microbiology · 179d
Cleared May 30, 2026
CoLink® & CoLag® Non-Sterile Screws
K261154 · HWC
In2bones USA, LLC
Orthopedic · 52d
Cleared May 29, 2026
GI Genius™ Module 300 (GGM300-US)
K261369 · QNP
Cosmo Artificial Intelligence - Ai, Ltd.
Gastroenterology & Urology · 32d
Cleared May 29, 2026
ENTire IRE System
K261202 · GEI
Entire Medical , Ltd.
General & Plastic Surgery · 46d
Cleared May 29, 2026
Exceed® Biplanar Expandable Interbody System
K261159 · MAX
Spine Wave, Inc.
Orthopedic · 51d
Cleared May 29, 2026
Navigated LLIF Impactable Tracker
K261060 · OLO
Tyber Medical, LLC
Orthopedic · 59d
Cleared May 29, 2026
Xpert PFP
K261038 · HRS
Newclip Technics
Orthopedic · 60d
Cleared May 29, 2026
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens...
K260507 · LPL
INTEROJO, Inc.
Ophthalmic · 101d
Cleared May 29, 2026
LASEmaR 1500
K260489 · GEX
Eufoton S.R.L.
General & Plastic Surgery · 105d
Cleared May 29, 2026
Injection Needle
K260262 · FBK
Mirco-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 121d
Cleared May 29, 2026
LUNE PureHygiene
K260138 · GEX
Enamel Pure
Dental · 133d
Cleared May 29, 2026
OrthoGrid Hip AI® 4.0
K260077 · QIH
OrthoGrid Systems, Inc.
Radiology · 137d
Cleared May 29, 2026
eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005,...
K254300 · HGX
Anker Innovations Limited
Obstetrics & Gynecology · 149d
Cleared May 29, 2026
BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
K254076 · FCM
C.R. Bard, Inc.
Gastroenterology & Urology · 162d