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
985–1008 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Apr 20, 2026
SAGI Cervical Cage System
K253213 · OVE
ZheJiang Decans Medical Devices Co.,...
Orthopedic · 203d
Cleared Apr 20, 2026
Non-sterile Level 3 Surgical Gown (4025)
K253003 · FYA
Hubei Xinxin Non-Woven Co., Ltd.
General Hospital · 213d
Cleared Apr 20, 2026
Lunar Astra
K252718 · KGI
GE Medical Systems Ultrasound &...
Radiology · 235d
Cleared Apr 20, 2026
Folliscan
K252332 · QIH
Mim Fertility
Radiology · 269d
Cleared Apr 20, 2026
SmartSurgN Visualization System
K242163 · OWN
Smartsurgn, Inc.
General & Plastic Surgery · 635d
Cleared Apr 17, 2026
Dura-Arch
K261261 · EBG
Hangzhou SHINING3D Dental Technology...
Dental · 1d
Cleared Apr 17, 2026
TITAN Nail
K260934 · HWC
Medartis AG
Orthopedic · 28d
Cleared Apr 17, 2026
Neonav ECG Tip Location System
K260929 · LJS
Navi Medical Technologies
Cardiovascular · 28d
Cleared Apr 17, 2026
DYNEX® External Fixation Systems
K260900 · KTT
Vilex, LLC
Orthopedic · 30d
Cleared Apr 17, 2026
MTS Gepotidacin 0.016-256 µg/mL
K260696 · JWY
Liofilchem S. R. L.
Microbiology · 45d
Cleared Apr 17, 2026
Edwards eSheath+ introducer set
K254279 · DYB
Edwards Lifesciences
Cardiovascular · 108d
Cleared Apr 17, 2026
Wovyn Depth Electrode
K253970 · GZL
Sensomedical Labs, Ltd.
Neurology · 127d
Cleared Apr 17, 2026
Novasight Hybrid System
K252945 · OBJ
Conavi Medical, Inc.
Cardiovascular · 214d
Cleared Apr 17, 2026
MySleepDash
K252338 · BZD
Somnetics International, Inc. (Dba...
Anesthesiology · 263d
Cleared Apr 17, 2026
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS)...
K252334 · KPI
Pontemedag
Gastroenterology & Urology · 263d
Cleared Apr 17, 2026
Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)
K252279 · FMF
Chirana T.Injecta,A.S.
General Hospital · 269d
Cleared Apr 17, 2026
EdgeFlow UW20
K252237 · IYO
Edgecare, Inc.
Radiology · 274d
Not Cleared Apr 17, 2026
XplantR Explant Tool
DEN250033 · SHR
Hjarta Care, LLC
Cardiovascular · 253d
Cleared Apr 16, 2026
Hot Pink Pad Warming System
K260903 · DWJ
Xodus Medical, Inc.
Cardiovascular · 29d
Cleared Apr 16, 2026
Redermo Wound Matrix
K260020 · QSZ
Beijing Kreate Medical Co., Ltd.
General & Plastic Surgery · 101d
Cleared Apr 16, 2026
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · OLO
Foundation Surgical Group, Inc.
Orthopedic · 104d
Cleared Apr 16, 2026
ARx® SAI Implant System
K254274 · NKB
Life Spine, Inc.
Orthopedic · 107d
Cleared Apr 16, 2026
Verisafe Safety Sterile Needles (SSN)
K254273 · FMI
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 107d
Cleared Apr 16, 2026
Next Generation 088 Catheter
K254223 · QJP
Balt USA, LLC
Neurology · 108d