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
24217–24240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 04, 2018
Prase MIS Spinal System
K182059 · NKB
Gbs Commonwealth Co., Ltd.
Orthopedic · 65d
Cleared Oct 04, 2018
Ureteric Catheters
K182122 · EYB
Coloplast Corp.
Gastroenterology & Urology · 59d
Cleared Oct 04, 2018
Encompass SRS Headframe
K182189 · IYE
Qfix
Radiology · 52d
Cleared Oct 04, 2018
HYBRID Guidewire
K182337 · MOF
Balt USA, LLC
Neurology · 37d
Cleared Oct 04, 2018
MAGLUMI 2000 FT4
K182423 · CEC
Shenzhen New Industries Biomedical...
Chemistry · 28d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Oct 04, 2018
PIXX 1717
K182533 · MQB
Pixxgen Corporation
Radiology · 20d
Cleared Oct 03, 2018
ARIX Clavicle System
K180972 · HRS
Jeil Medical Corporation
Orthopedic · 173d
Cleared Oct 03, 2018
IS-III active System
K181138 · DZE
Neobiotech Co., Ltd.
Dental · 156d
Cleared Oct 03, 2018
Caretaker Remote Display App and Caretaker Software Library
K181196 · DRG
Caretaker Medical, LLC
Cardiovascular · 149d
Cleared Oct 03, 2018
uMR 780
K181370 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
uMR 790
K181371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Oct 03, 2018
Outlet Sacroiliac Joint Fusion System
K181881 · OUR
Sij Surgical
Orthopedic · 82d
Cleared Oct 03, 2018
FIREFLY® Midline Navigation Guide
K181883 · PQC
Mighty Oak Medical, Inc.
Orthopedic · 82d
Cleared Oct 03, 2018
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes,...
K181903 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared Oct 03, 2018
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation...
K182050 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Oct 03, 2018
Vinyl Patient Examination Gloves
K182115 · LYZ
Pingan Medical Products Co., Ltd.
General Hospital · 58d
Cleared Oct 03, 2018
2MP Color LCD Monitor CL-R211
K182539 · PGY
Jvckenwood Corporation
Radiology · 19d
Cleared Oct 02, 2018
NOxBOXi Nitric Oxide Delivery System
K171696 · MRN
Praxair Distribution, Inc.
Anesthesiology · 482d
Cleared Oct 02, 2018
KLOCKNER SURGICAL BOX
K173642 · KCT
SOADCO, S.L.
General Hospital · 312d
Cleared Oct 02, 2018
Infrared Ear Thermometer
K181081 · FLL
Joytech Healthcare Co. , Ltd.
General Hospital · 161d
Cleared Oct 02, 2018
Deka Smartxide2 Trio
K181867 · GEX
El.En Electronic Engineering Spa
General & Plastic Surgery · 82d
Cleared Oct 02, 2018
Voyant System
K181885 · HRX
Viseon, Inc.
General & Plastic Surgery · 81d