FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: 2026–2026 ×
2,517 results
217–240 of 2,517
Search insights Median review: 135d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared Sep 14, 2026
RIVA® Posterior Fixation System with NanoACTIV Surface Technology
K262193 · NKB
Xenix Medical
Orthopedic · 77d
Cleared Sep 14, 2026
BD BBL Mueller Hinton II Broth (Cation-Adjusted)
K262163 · JTZ
Becton, Dickinson and Company
Microbiology · 80d
Cleared Sep 14, 2026
qCT Lung (v1.0)
K261517 · QDQ
Qure.Ai Technologies Pvt. , Ltd.
Radiology · 130d
Cleared Sep 14, 2026
HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
K261438 · DTZ
Eurosets S.R.L
Cardiovascular · 137d
Cleared Sep 14, 2026
Radical 064 Reperfusion Catheter
K261089 · NRY
Maduro Medical, Inc.
Neurology · 166d
Cleared Sep 14, 2026
Hand-held Dental X-ray System (HyperLight-M)
K260795 · EHD
Changzhou Sifary Medical Technology...
Radiology · 187d
Cleared Sep 14, 2026
Yumizen H550
K260781 · GKZ
HORIBA ABX SAS
Hematology · 188d
Cleared Sep 14, 2026
colonic FTRD Set (200.70)
K253481 · PKL
Ovesco Endoscopy AG
Gastroenterology & Urology · 335d
Cleared Sep 13, 2026
Safety lancet (XL)
K262526 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 53d
Cleared Sep 12, 2026
Digistat Care
K261287 · MSX
Ascom Ums Srl Unipersonale
Cardiovascular · 145d
Cleared Sep 12, 2026
CADDIE
K260133 · QNP
Odin Medical Limited
Gastroenterology & Urology · 239d
Cleared Sep 11, 2026
CraniUS Plate
K262874 · GWO
CraniUS, LLC
Neurology · 28d
Cleared Sep 11, 2026
PureLift Pro Max
K262861 · NFO
Xtreem Pulse, LLC
Neurology · 29d
Cleared Sep 11, 2026
iLet Dosing Decision Software
K262763 · QJI
Beta Bionics, Inc.
Chemistry · 38d
Cleared Sep 11, 2026
CuratOR EX2742
K262397 · GCJ
Eizo Corporation
General & Plastic Surgery · 59d
Cleared Sep 11, 2026
Mg OSTEOREVIVE™
K262230 · MQV
Bone Solutions, Inc.
Orthopedic · 73d
Cleared Sep 11, 2026
SpaceOAR Flex™ System
K262151 · OVB
Boston Scientific Corporation
Radiology · 78d
Cleared Sep 11, 2026
Vioseal X
K262050 · KIF
Spident Co., Ltd.
Dental · 85d
Cleared Sep 11, 2026
Innovasis AxTiHA® Stand-Alone ALIF System
K262025 · OVD
INNO Holdings Inc. DBA Innovasis
Orthopedic · 87d
Cleared Sep 11, 2026
PRIMED AAMI Level 3 Open Back Gowns
K262007 · QPC
Primed Medical Products, Inc.
General Hospital · 88d
Cleared Sep 11, 2026
FINDER Flu A&B/SARS-CoV-2 Test
K261837 · QOF
Baebies, Inc.
Microbiology · 101d
Cleared Sep 11, 2026
Sequential Circulator (SC-4004-DL, SC-4008-DL)
K261807 · JOW
Bio Compression Systems, Inc.
Cardiovascular · 102d
Cleared Sep 11, 2026
ZBPro Diagnostic (Version 2.0)
K261580 · MLO
Zbeats, Inc.
Cardiovascular · 121d
Cleared Sep 11, 2026
RENASYS DYNAFLOW Kit (66807741)
K261338 · OMP
Smith & Nephew Medical, Ltd.
General & Plastic Surgery · 141d