FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
289–312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 2026
Pectus Blu System
K261002 · HRS
Biomet Microfixation
Orthopedic · 68d
Cleared Jun 02, 2026
Manual Wheelchair (LW01108)
K260642 · IOR
Anhui Longway Medical Technology Co.,...
Physical Medicine · 95d
Cleared Jun 02, 2026
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · OLO
Life Spine, Inc.
Orthopedic · 103d
Cleared Jun 02, 2026
DB 4000 High Impact Denture Base
K260569 · EBI
Carbon, Inc.
Dental · 103d
Cleared Jun 02, 2026
Device 300419 Strip
K260364 · MQV
Geistlich Pharma AG
Orthopedic · 118d
Cleared Jun 02, 2026
FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)
K260270 · CAF
FindAir Sp. z o.o.
Anesthesiology · 125d
Cleared Jun 02, 2026
Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St)
K253918 · GEI
F Care Systems USA, LLC
General & Plastic Surgery · 176d
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