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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
73465–73488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 2002
EXPORT ASPIRATION CATHETER
K023303 · NFA
Medtronic Vascular
Cardiovascular · 26d
Cleared Oct 29, 2002
1CC FUTURA SAFETY SYRINGE
K023323 · MEG
Futura Medical Technology
General Hospital · 25d
Cleared Oct 29, 2002
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
K023471 · LZG
Disetronic Medical Systems AG
General Hospital · 14d
Cleared Oct 28, 2002
ARTERIA OCCLUSION BALLOON
K021210 · MJN
Arteria Medical Science, Inc.
Cardiovascular · 194d
Cleared Oct 28, 2002
NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
K021541 · JNB
Perkinelmer Life Sciences
Chemistry · 171d
Cleared Oct 28, 2002
KARATS MULTIPURPOSE SOLUTION
K021635 · LPN
Ciba Vision Corporation
Ophthalmic · 164d
Cleared Oct 28, 2002
ACON MDMA ONE STEP ECSTASY TEST STRIP & ACON MDMA ONE STEP ECSTASY TEST DEVICE
K022589 · LAF
ACON Laboratories, Inc.
Chemistry · 84d
Cleared Oct 28, 2002
IBOND GLUMA INSIDE
K022612 · KLE
Heraeus Kulzer, Inc.
Dental · 83d
Cleared Oct 28, 2002
ELITE MONOPHASE
K022653 · ELW
Zhermack S.P.A.
Dental · 80d
Cleared Oct 28, 2002
MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE...
K022941 · LFR
Abbott Laboratories
Chemistry · 55d
Cleared Oct 28, 2002
PQ1
K023042 · KLE
Ultradent Products, Inc.
Dental · 46d
Cleared Oct 28, 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200...
K023262 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 28d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300 · DQX
Guidant Corp.
Cardiovascular · 25d
Cleared Oct 28, 2002
ENVIRON-NP DISPOSABLE SYNTHETIC VINYL EXAM GLOVES, POWDERED
K023343 · LYZ
Shanghai Palomar Mountain Industries,...
General Hospital · 21d
Cleared Oct 28, 2002
TRUCATH.IP
K023368 · DFG
Aortech Critical Care , Ltd.
Immunology · 20d
Cleared Oct 25, 2002
DORNIER DIODE LASER FAMILY MEDILAS D, MEDILAS D SKINPULSE & MEDILAS D...
K020339 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 266d
Cleared Oct 25, 2002
DR. JAPAN FACIL POINT SPINAL NEEDLE
K020934 · BSP
Myco Medical, Inc.
Anesthesiology · 217d
Cleared Oct 25, 2002
SENSUA!
K021125 · HIS
Aac Consulting Group, Inc.
Obstetrics & Gynecology · 200d
Cleared Oct 25, 2002
CONDOMI NATURE, CONDOMI STIMULATION, CONDOMI VANILLA GOLD, CONDOMI SUPERSAFE,...
K021186 · HIS
Condomi Erfert...
Obstetrics & Gynecology · 193d
Cleared Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
K021190 · GJS
Roche Diagnostics Corp.
Hematology · 193d
Cleared Oct 25, 2002
VECTORVISION CT-FREE KNEE
K021306 · HAW
Brainlab AG
Neurology · 184d
Cleared Oct 25, 2002
INCOMPASS SPINAL FIXATION SYSTEM
K021564 · KWQ
Spinal Concepts, Inc.
Orthopedic · 165d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 25, 2002
RINGLOC CONSTRAINED LINERS
K021661 · KWZ
Biomet Orthopedics, Inc.
Orthopedic · 158d