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
39193–39216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 14, 2013
PEREGRINE CURVED ILLUMINATING LASER PROBE
K132614 · HQB
Peregrine Surgical , Ltd.
Ophthalmic · 85d
Cleared Nov 14, 2013
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K133208 · KRD
Boston Scientific Corp
Cardiovascular · 27d
Cleared Nov 13, 2013
SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS
K122252 · NVP
Medical Developments International
Anesthesiology · 474d
Cleared Nov 13, 2013
KULAVAC
K122490 · OMP
CG Bio Co., Ltd.
General & Plastic Surgery · 455d
Cleared Nov 13, 2013
IDYS(TM) C
K130853 · ODP
Clariance
Orthopedic · 230d
Cleared Nov 13, 2013
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
K131128 · DIO
Omega Laboratories, Inc.
Toxicology · 204d
Cleared Nov 13, 2013
MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA...
K131904 · FIP
Ameriwater
Gastroenterology & Urology · 141d
Cleared Nov 13, 2013
U&U STERILE HYPODERMIC NEEDLE
K132552 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 91d
Cleared Nov 13, 2013
BD Veritor™ System Flu A+B Assay
K133138 · PSZ
Becton, Dickinson & CO
Microbiology · 27d
Cleared Nov 12, 2013
I RUNE (I-200L)
K122410 · NUH
Medirune Co, Ltd.
Neurology · 461d
Cleared Nov 12, 2013
SPECTRUM SPINE SPINOUS PROCESS DEVICE
K130066 · PEK
Spectrum Spine IP Holdings, LLC
Orthopedic · 306d
Cleared Nov 12, 2013
SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
K130848 · IOR
Shanghai Phoenix Medical Equipment...
Physical Medicine · 231d
Cleared Nov 12, 2013
NON-CONTACT INFRARED THERMOMETER
K131243 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 195d
Cleared Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085 · LCX
Co-Innovation Biotech Co., Ltd.
Chemistry · 130d
Cleared Nov 12, 2013
BECE CAD ZIRKON HT+
K132102 · EIH
Bego Bremer Goldschlaegerei Wilh....
Dental · 127d
Cleared Nov 12, 2013
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
K132106 · JAA
Toshiba America Medical Systems, In.C
Radiology · 127d
Cleared Nov 12, 2013
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML,...
K132276 · KPE
Hospira, Inc.
General Hospital · 113d
Cleared Nov 12, 2013
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
K132294 · KPR
Radiology Solutions, LLC
Radiology · 112d
Cleared Nov 12, 2013
BIOGRAPH MMR
K133226 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Nov 12, 2013
QUADROX-IR ADULT AND SMALL ADULT
K133265 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 20d
Cleared Nov 09, 2013
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759 · HSD
Fx Solutions
Orthopedic · 234d
Cleared Nov 09, 2013
CAYMAN MI PLATE SYSTEM
K131533 · KWQ
K2m, Inc.
Orthopedic · 168d
Cleared Nov 08, 2013
K-Y BRAND LIQUIBEADS
K122061 · NUC
Johnson & Johnson Healthcare Products
Obstetrics & Gynecology · 483d
Cleared Nov 08, 2013
BYTECH
K130101 · LYZ
Bytech Dongtai Co., Ltd.
General Hospital · 297d