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: Cleared only ×
175,230 results
25729–25752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
K180194 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 30, 2018
Vitrea Software Package
K180323 · LLZ
Canon Medical Systems Corporation
Radiology · 53d
Cleared Mar 30, 2018
gammaCore Sapphire
K180538 · PKR
Electrocore, LLC
Neurology · 30d
Cleared Mar 30, 2018
G-scan Brio
K180592 · LNH
Esaote, S.P.A.
Radiology · 24d
Cleared Mar 29, 2018
IXOS Radius Plate System
K171624 · HRS
Stuckenbrock Medizintechnik GmbH
Orthopedic · 300d
Cleared Mar 29, 2018
Arthrex Shoulder System
K171841 · KWS
Arthrex, Inc.
Orthopedic · 282d
Cleared Mar 29, 2018
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo...
K172071 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 262d
Cleared Mar 29, 2018
OLYMPUS URF-P6/P6R
K172298 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 241d
Cleared Mar 29, 2018
Atellica IM Total hCG (ThCG)
K172322 · JHI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 240d
Cleared Mar 29, 2018
TwitchView System
K172843 · KOI
Blink Device Corporation
Anesthesiology · 191d
Cleared Mar 29, 2018
Zimmer Knee Joint Replacement Prostheses MR Labeling
K173057 · JWH
Zimmer, Inc.
Orthopedic · 182d
Cleared Mar 29, 2018
Arco™-SA Lumbar Cage System
K173082 · OVD
Neurostructures, Inc.
Orthopedic · 181d
Cleared Mar 29, 2018
Bloom2 Programmable Electrophysiology Stimulator
K173439 · JOQ
Fischer Medical
Cardiovascular · 146d
Cleared Mar 29, 2018
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
K173533 · EZL
Poiesis Medical, LLC
Gastroenterology & Urology · 134d
Cleared Mar 29, 2018
NaviCross 0.018
K173799 · DQY
Terumo Corporation
Cardiovascular · 105d
Cleared Mar 29, 2018
CorPath GRX System
K180517 · DXX
Corindus, Inc.
Cardiovascular · 30d
Cleared Mar 29, 2018
NovoStitch Pro Meniscal Repair System
K180531 · GAT
Ceterix Orthopaedics, Inc.
General & Plastic Surgery · 29d
Cleared Mar 29, 2018
Voluson P6 and Voluson P8
K180535 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 28, 2018
Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket,...
K171969 · LQR
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Mar 28, 2018
CoreHip® System
K172235 · LZO
Aesculap Implants Systems, LLC
Orthopedic · 246d
Cleared Mar 28, 2018
ROSA BRAIN (v3.0.0.5)
K172444 · HAW
Medtech S.A
Neurology · 226d
Cleared Mar 28, 2018
David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
K172627 · LCX
Runbio Biotech Co.,Ltd
Chemistry · 208d
Cleared Mar 28, 2018
Concentrix MX-AC High-Speed Handpiece
K173465 · EFB
Dentalez, Inc.
Dental · 140d
Cleared Mar 28, 2018
GYN-Pump PH304
K173489 · HIG
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 135d