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
137425–137448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1987
CLOSED WOUND DRAINAGE SYSTEMS
K874645 · GCY
Hall Laboratories, Inc.
General & Plastic Surgery · 19d
Cleared Dec 01, 1987
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS
K873857 · JDI
Dow Corning Wright
Orthopedic · 70d
Cleared Dec 01, 1987
ABBOTT PAP-EIA
K873903 · JFH
Abbott Laboratories
Chemistry · 68d
Cleared Nov 30, 1987
OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE
K871517 · DQX
Olympus Corp.
Cardiovascular · 224d
Cleared Nov 30, 1987
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
K873367 · FEO
Olympus Corp.
Gastroenterology & Urology · 101d
Cleared Nov 30, 1987
LIFECARE EXHALATION VALVE #06-699
K873570 · CBP
Lifecare Services, Inc.
Anesthesiology · 89d
Cleared Nov 30, 1987
GAIT-AID ORTHOPEDIC INSOLE
K874502 · IQI
Gait-Aid, Inc.
Physical Medicine · 28d
Cleared Nov 27, 1987
TELEPHONE DEFIBRILLATOR SYSTEM
K864257 · LDD
Medphone Corp.
Cardiovascular · 394d
Cleared Nov 27, 1987
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K872948 · JOL
Uresil Corp.
General Hospital · 122d
Cleared Nov 27, 1987
CLOSED FOLEY CATHETER SYSTEM
K873288 · KNY
Todd Medical, Inc.
Gastroenterology & Urology · 102d
Cleared Nov 27, 1987
REFLEX(TM) CA-T CLIP APPLIER
K873309 · FZP
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 101d
Cleared Nov 27, 1987
USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER
K873438 · DQO
C.R. Bard, Inc.
Cardiovascular · 92d
Cleared Nov 27, 1987
ROTASCREEN EIA
K873740 · LIQ
Mercia Diagnostics , Ltd.
Microbiology · 73d
Cleared Nov 27, 1987
SUPERPULSE AMBULASE (XAM-SP) CO2 SURGICAL LASER
K873760 · GEX
Coherent Medical Group
General & Plastic Surgery · 72d
Cleared Nov 27, 1987
REUMA TEST
K873782 · DHR
Sclavo, Inc.
Immunology · 72d
Cleared Nov 27, 1987
DYNAMARK 1000
K873979 · DXN
Dynamedics, Inc.
Cardiovascular · 58d
Cleared Nov 27, 1987
LAD MODEL 735 LUMINOMETER
K874262 · JJQ
Los Alamos Diagnostics
Chemistry · 38d
Cleared Nov 27, 1987
CONCEPT SUTURE NEEDLE
K874515 · HRX
Concept, Inc.
Orthopedic · 25d
Cleared Nov 25, 1987
O.P.T.(TM) OVULATION PREDICTION TEST
K870584 · CEP
Warner-Lambert Co.
Chemistry · 287d
Cleared Nov 25, 1987
ARTHROBOT 100 UPPER LIMB POSITIONER
K873079 · JEA
Andronic Devices, Ltd.
General & Plastic Surgery · 112d
Cleared Nov 25, 1987
ARTHROBOT 101 UPPER LIMB TRACTION ACCESSORY
K873080 · JEA
Andronic Devices, Ltd.
General & Plastic Surgery · 112d
Cleared Nov 25, 1987
VIDEO ARTHROSCOPE, 1.7MM X 55 MM
K873387 · HXR
Arthropedics, Inc.
General & Plastic Surgery · 152d
Cleared Nov 25, 1987
CANNULA AND GENERAL PURPOSE ASPIRATOR
K873552 · HHI
Cosmedtech, Inc.
Obstetrics & Gynecology · 107d
Cleared Nov 25, 1987
BIOSURE SPECIMEN COLLECTION CONTAINER
K873593 · KDT
Biosure, Inc.
Pathology · 82d