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
1825–1848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 2025
EXEL Disposable Syringe
K251089 · FMF
Exelint International, Co.
General Hospital · 246d
Cleared Dec 12, 2025
iHealth Flu A&B/COVID-19/RSV Rapid Test
K251085 · SCA
Ihealth Labs, Inc.
Microbiology · 247d
Cleared Dec 12, 2025
Bio Arterial Deluxe (IC-BAP-DX)
K250974 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 256d
Cleared Dec 12, 2025
FUJIFILM Ultrasonic Endoscope EB-710US
K250863 · EOQ
Fujifilm Corporation
Ear, Nose, Throat · 266d
Cleared Dec 12, 2025
VaporShield
K250847 · MEG
Vault Paragon Group, Inc.
General Hospital · 267d
Cleared Dec 12, 2025
Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon...
K250821 · DTZ
Eurosets S.R.L
Cardiovascular · 269d
Cleared Dec 12, 2025
Cerynë Intimate Care
K250488 · NUC
Ansella Therapeutics
Obstetrics & Gynecology · 296d
Cleared Dec 12, 2025
Jason membrane
K242817 · NPL
Botiss Biomaterials GmbH
Dental · 450d
Cleared Dec 11, 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · OVE
4Web Medical, Inc.
Orthopedic · 76d
Cleared Dec 11, 2025
DeepRhythmAI
K253141 · DQK
Medicalgorithmics S.A.
Cardiovascular · 77d
Cleared Dec 11, 2025
HyperFlex® Bunion Correction System
K252997 · HRS
Hyperflex Medical
Orthopedic · 84d
Cleared Dec 11, 2025
HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops
K252941 · FXX
O&M Halyard, Inc.
General Hospital · 87d
Cleared Dec 11, 2025
APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw)
K252897 · HRS
A Plus Biotechnology Co., Ltd.
Orthopedic · 91d
Cleared Dec 11, 2025
Target Detachable Coil
K252694 · HCG
Stryker Neurovascular
Neurology · 107d
Cleared Dec 11, 2025
CogNet AI-MT+
K252482 · QFM
Medcognetics, Inc.
Radiology · 126d
Cleared Dec 11, 2025
MIM – LesionID Pro
K251883 · LLZ
Mim Software, Inc.
Radiology · 174d
Cleared Dec 11, 2025
KLS Martin Pure Pectus System
K250988 · HRS
KLS-Martin L.P.
Orthopedic · 255d
Cleared Dec 10, 2025
ARIX Femur Nail System
K252826 · HSB
Jeil Medical Corporation
Orthopedic · 96d
Cleared Dec 10, 2025
SANSA HSAT
K252497 · MNR
Huxley Medical
Anesthesiology · 124d
Cleared Dec 10, 2025
Intellidrop
K251598 · JXG
Brainspace, Inc.
Neurology · 197d
Cleared Dec 10, 2025
Verisafe Safety Retractable Insulin Syringes
K250192 · FMF
Promisemed Hangzhou Meditech Co., Ltd.
General Hospital · 321d
Cleared Dec 09, 2025
Lancing device (HH-XV-T)
K253706 · QRL
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 15d
Cleared Dec 09, 2025
GlasIonomer FX-LC
K252808 · EMA
Shofu Dental Corporation
Dental · 97d
Cleared Dec 09, 2025
Atlantis® Abutments in Titanium
K252343 · NHA
Dentsply Sirona
Dental · 134d