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
37345–37368 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 13, 2014
BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE...
K140759 · MAX
Medos International SARL
Orthopedic · 79d
Cleared Jun 13, 2014
CELERITY SYSYEM
K140799 · LJS
Medcomp (Medical Components, Inc.)
General Hospital · 74d
Cleared Jun 13, 2014
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K140960 · LLZ
Hologic, Inc.
Radiology · 59d
Cleared Jun 13, 2014
LZI HYDROCODONE
K141055 · DJG
Lin-Zhi International, Inc.
Toxicology · 50d
Cleared Jun 13, 2014
ACUMED HAND FRACTURE SYSTEM
K141383 · HRS
Acumed, LLC
Orthopedic · 17d
Cleared Jun 13, 2014
ALERE I INFLUENZA A & B
K141520 · OCC
Alere Scarborough, Inc D/B/A Binax, Inc.
Microbiology · 4d
Cleared Jun 12, 2014
GENISTRONG SINGLE-USE SPECIMEN RETRIEVAL BAG
K132375 · GCJ
Genicon
General & Plastic Surgery · 317d
Cleared Jun 12, 2014
TERUMO SURFLO I.V. CATHETER
K133280 · FOZ
Terumo (Philippines) Corporation
General Hospital · 230d
Cleared Jun 12, 2014
JIAWANG
K140239 · LYZ
Jiawang Glove Co., Ltd.
General Hospital · 133d
Cleared Jun 12, 2014
ZHAOFENG
K140240 · LYZ
Zhaofeng Glove Co., Ltd.
General Hospital · 133d
Cleared Jun 12, 2014
FEIYUE
K140242 · LYZ
Feiyue Glove Co., Ltd.
General Hospital · 133d
Cleared Jun 12, 2014
WARTIE WART REMOVER
K140314 · GEH
Yonmedical BV
General & Plastic Surgery · 122d
Cleared Jun 12, 2014
WHITE VINYL EXAM GLOVES POWDER FREE
K140322 · LYZ
Shandong Dawei Medical Products Co.,...
General Hospital · 122d
Cleared Jun 12, 2014
META-C CERVICAL PLATE
K140361 · KWQ
Medacta International
Orthopedic · 120d
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE,...
K140695 · DQX
Medtronic, Inc.
Cardiovascular · 85d
Cleared Jun 12, 2014
VIAL2BAG DIRECT CONNECT
K140730 · LHI
Medimop Medical Projects, Ltd.
General Hospital · 80d
Cleared Jun 12, 2014
AFFINITY PIXIE OXYGENATION SYSTEM WITH
K141233 · DTN
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jun 12, 2014
TEVADAPTOR
K141306 · FPA
Teva Medical Ltd., Migada Plant
General Hospital · 24d
Cleared Jun 12, 2014
TRIPLEPLAY PRO
K141360 · JOW
Wildcat Medical, Inc.
Cardiovascular · 20d
Cleared Jun 12, 2014
DURADIAGNOST
K141381 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 16d
Cleared Jun 11, 2014
DIGITAL ELECTROCARDIOGRAPH
K131858 · DPS
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 352d
Cleared Jun 11, 2014
JO PREMIUM PERSONAL LUBRICANT
K132954 · NUC
United Consortium
Obstetrics & Gynecology · 264d
Cleared Jun 11, 2014
OPTICAL BIOMETER AL-SCAN
K133132 · HJO
Nidek Co., Ltd.
Ophthalmic · 254d
Cleared Jun 11, 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT...
K133403 · LPL
Firestone Optics, Inc.
Ophthalmic · 217d