FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
173209–173232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1977
BLADES, SCALPEL
K771045 · GES
American Safety Razor Co.
General & Plastic Surgery · 12d
Cleared Jun 22, 1977
VENA CAVA UMBRELLA FILTER, MODEL 7321
K771046 · DTK
Edwards Laboratories
Cardiovascular · 12d
Cleared Jun 20, 1977
PRESERVE LUBRICANT CODE NO. 43=4035
K770498 · KMJ
Codman & Shurtleff, Inc.
General Hospital · 98d
Cleared Jun 20, 1977
NEEDLE, BIOPSY, BOYD, LUNG
K770523
Cook, Inc.
Pathology · 94d
Cleared Jun 20, 1977
CONNECTORS
K770596 · FPK
Abco Dealers, Inc.
General Hospital · 84d
Cleared Jun 20, 1977
TOOTHBRUSH, REACH
K770749 · EFW
Johnson & Johnson Professionals, Inc.
Dental · 56d
Cleared Jun 20, 1977
GENERATOR, PULSE, UNIPOLAR, #508
K770880 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 35d
Cleared Jun 20, 1977
GENERATOR, PULSE, BIPOLAR 3608
K770881 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 35d
Cleared Jun 20, 1977
NEURO-SORB PATTIES
K770894 · HBA
Instranetics, Inc.
Neurology · 35d
Cleared Jun 20, 1977
CARDIAC PACERS W/NARROW PULSE WIDTH
K770951 · DXY
Cordis Corp.
Cardiovascular · 26d
Cleared Jun 20, 1977
SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE
K770967 · EIC
National Patent Development Corp.
Dental · 20d
Cleared Jun 20, 1977
DENTAL PLAQUE DISCLOSING AGENT
K770990 · QJC
Evident Dental Co. , Ltd.
Dental · 20d
Cleared Jun 20, 1977
PRO-CARE
K770997 · JEQ
Young Dental Manufacturing Co. 1, LLC
Dental · 19d
Cleared Jun 20, 1977
ARTICULATING PAPER
K771011 · EFH
Parker Laboratories, Inc.
Dental · 14d
Cleared Jun 20, 1977
HUANG VEIN HOLDER, #21-8011
K771026 · DWS
Codman & Shurtleff, Inc.
Cardiovascular · 12d
Cleared Jun 17, 1977
PROPHALACTICS
K770412 · HIS
Jamar Health Products
Obstetrics & Gynecology · 105d
Cleared Jun 17, 1977
ATYPIA PROFILE MONITOR
K770550 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 88d
Cleared Jun 17, 1977
DETER. OF PHOSPHOHEXOSE ISOMERASE
K770577 · KLJ
Sigma Chemical Co.
Chemistry · 81d
Cleared Jun 17, 1977
LDH ULTRAZYME PLUS
K770613 · CFJ
Harleco Diagnostics
Chemistry · 78d
Cleared Jun 17, 1977
EXERCISER, LEG, LOWER EXTREMITY
K770658 · ION
Robert R. Moore
Physical Medicine · 71d
Cleared Jun 17, 1977
IN VITRO FERRITIN RIA TEST
K770702 · DBF
Clinical Assays, Inc.
Immunology · 60d
Cleared Jun 17, 1977
REAGENT, CHLORIDE, COULTER
K770752 · CHJ
Coulter Electronics, Inc.
Chemistry · 53d
Cleared Jun 17, 1977
PHENYTOIN RIA KIT
K770779 · DLP
Amersham Corp.
Toxicology · 49d
Cleared Jun 17, 1977
RELAXATION COURSE MOLEL 1000
K770787 · HCC
Cybernetic Medical, Inc.
Neurology · 46d