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
40369–40392 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 2013
LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL...
K130295 · NBW
Infopia Co, Ltd.
Chemistry · 135d
Cleared Jun 21, 2013
CERTAIN BELLATEK PROVISIONAL ABUTMENTS
K130310 · NHA
Biomet 3i
Dental · 134d
Cleared Jun 21, 2013
HYRDROMAX HMEF
K130664 · CAH
A-M Systems
General Hospital · 101d
Cleared Jun 21, 2013
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
K130816 · GXY
Neuro Resource Group, Inc.
Neurology · 88d
Cleared Jun 21, 2013
DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K130833 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 87d
Cleared Jun 21, 2013
FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K130914 · PEN
Biofire Diagnostics, Inc.
Microbiology · 80d
Cleared Jun 21, 2013
E.G. SCAN(TM) II ESOPHAGOSCOPE SYSTEM
K131131 · EOX
Intromedic Co., Ltd.
Ear, Nose, Throat · 60d
Cleared Jun 21, 2013
DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM
K131213 · IYN
Sonoscape Company Limited
Radiology · 53d
Cleared Jun 21, 2013
VERRATA PRESSURE GUIDE WIRE
K131288 · DQX
Volcano Corporation
Cardiovascular · 46d
Cleared Jun 20, 2013
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · HBA
American Surgical Company, LLC
Neurology · 652d
Cleared Jun 20, 2013
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT
K121101 · JIA
Astoria-Pacific, Inc.
Chemistry · 435d
Cleared Jun 20, 2013
PHYSIOLOGICAL DATA PROCESSOR
K122763 · DRG
Zephyr Technology Corporation
Cardiovascular · 283d
Cleared Jun 20, 2013
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
K123106 · KPR
Samsung Electronics Co., Ltd.
Radiology · 261d
Cleared Jun 20, 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · MBI
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared Jun 20, 2013
REFORM PEDICLE SCREW SYSTEM
K130279 · MNI
Spinal USA
Orthopedic · 135d
Cleared Jun 20, 2013
ARROW GPSCATH BALLOON DILATATION CATHETER
K130397 · LIT
Hotspur Technologies
Cardiovascular · 121d
Cleared Jun 20, 2013
FUTURABOND UNIVERSAL
K130486 · KLE
Voco GmbH
Dental · 115d
Cleared Jun 20, 2013
AIRCAST VENAFLOW ELITE SYSTEM
K130722 · JOW
Djo, LLC
Cardiovascular · 94d
Cleared Jun 20, 2013
CELLTRACKS ANALYZER II SYSTEM
K130794 · NQI
Veridex, LLC
Pathology · 90d
Cleared Jun 20, 2013
TITAN
K130795 · EWO
Interacoustics A/S
Ear, Nose, Throat · 90d
Cleared Jun 20, 2013
EXPEDIUM SPINE SYSTEM
K130877 · NKB
Medos International SARL
Orthopedic · 83d
Cleared Jun 20, 2013
XPERT MRSA/SA BLOOD CULTURE ASSAY
K130894 · NQX
Cepheid
Microbiology · 80d
Cleared Jun 20, 2013
TAMPAX(R) L PLASTIC TAMPONS, UNSCENTED
K131543 · HEB
Procter & Gamble Co.
Obstetrics & Gynecology · 22d
Cleared Jun 19, 2013
HUMAN ALBUMIN CSF KIT
K121045 · DCF
The Binding Site Group , Ltd.
Immunology · 439d