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
37249–37272 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 25, 2014
OPTIMUS FUSION: SLT, YAG AND YAG/SLT
K140336 · HQF
Quantel Medical
Ophthalmic · 135d
Cleared Jun 25, 2014
VENUS SWAN(MP)2
K140629 · GEI
Venus Concept , Ltd.
General & Plastic Surgery · 106d
Cleared Jun 25, 2014
VARIANT II TURBO LINK HEMOGLOBIN A1C PROGRAM/TESTING SYSTEM
K140801 · LCP
Bio-Rad Laboratories, Inc.
Chemistry · 86d
Cleared Jun 25, 2014
TRUKLEAR BRACKET
K141104 · NJM
Ajw Technology Consultants, Inc.
Dental · 57d
Cleared Jun 24, 2014
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN...
K133083 · DBF
Diazyme Laboratories
Immunology · 267d
Cleared Jun 24, 2014
BREEZE NEBULIZER (NBR-10X)
K133105 · CAF
Digio2 International Co., Ltd.
Anesthesiology · 267d
Cleared Jun 24, 2014
IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL
K133816 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 190d
Cleared Jun 24, 2014
MOBIUS3D
K140660 · IYE
Mobius Medical Systems, LP
Radiology · 102d
Cleared Jun 23, 2014
CONTOUR NEXT EZ BLOOD GLUCOSE METER
K130265 · NBW
Bayer Healthcare, LLC
Chemistry · 504d
Cleared Jun 23, 2014
NOVOPRESS
K131416 · JOW
Milka, LLC
Cardiovascular · 403d
Cleared Jun 23, 2014
RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K133193 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 249d
Cleared Jun 23, 2014
CLIQ DV-300 ASPIRATOR
K140809 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 83d
Cleared Jun 23, 2014
SUPOLENE
K141072 · GAT
Resorba Medical GmbH
General & Plastic Surgery · 59d
Cleared Jun 23, 2014
LIQUICHEK TUMOR MARKER CONTROL
K141073 · JJY
Bio-Rad Laboratories
Immunology · 59d
Cleared Jun 23, 2014
APTUS ULNA SHORTENING 2.5
K141232 · HRS
Medartis AG
Orthopedic · 41d
Cleared Jun 20, 2014
SERVO-I VENTILATOR SYSTEM
K123149 · CBK
Maquet Critical Care AB
Anesthesiology · 623d
Cleared Jun 20, 2014
INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
K132489 · CAW
Inogen, Inc.
Anesthesiology · 316d
Cleared Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
K132697 · LPH
Ortho Development Corp.
Orthopedic · 295d
Cleared Jun 20, 2014
DIAPHRAGMATIC HERNIA GRAFT
K133011 · OWV
Cook Biotech, Inc.
General & Plastic Surgery · 268d
Cleared Jun 20, 2014
DISCOVERY SYSTEM
K133062 · HJO
Innovative Visual Systems
Ophthalmic · 266d
Cleared Jun 20, 2014
BRACCO INJEENERING TRANSFER SET
K133147 · PQH
Bracco Injeneering S.A.
General Hospital · 246d
Cleared Jun 20, 2014
ADMIRE
K133646 · JAK
Siemens Medical Systems, Inc.
Radiology · 205d
Cleared Jun 20, 2014
THERMEDX FLUID MANAGMENT SYSTEM
K133799 · HIG
Thermedx, LLC
Obstetrics & Gynecology · 189d
Cleared Jun 20, 2014
PERSEUS A500
K133886 · BSZ
Draeger Medical GmbH
Anesthesiology · 182d