Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
72913–72936 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 2003
VITALCARE URETHRAL CATHETER
K021938 · GBM
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
VITALCARE FOLEY CATHETER
K021939 · EZL
Vitalcare, Inc.
Gastroenterology & Urology · 314d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Apr 22, 2003
NOVAVISION, MODEL 2.0
K023623 · HPT
Novavision, Inc.
Neurology · 175d
Cleared Apr 22, 2003
INSORB ABSORBABLE STAPLES, MODEL SP-B20
K024117 · GDW
Incisive Surgical, Inc.
General & Plastic Surgery · 130d
Cleared Apr 22, 2003
WORRY-REMOVER IRRIGATOR
K030056 · HED
Corisen Group, Ltd.
Obstetrics & Gynecology · 106d
Cleared Apr 22, 2003
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K030129 · DQK
Endocardial Solutions, Inc.
Cardiovascular · 98d
Cleared Apr 22, 2003
BABY POD
K030283 · FPP
Prism Enterprises, Inc.
General Hospital · 85d
Cleared Apr 22, 2003
SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM
K030310 · HRS
Synthes (Usa)
Orthopedic · 82d
Cleared Apr 22, 2003
STEELEX ELECTRODE SET
K030556 · LDF
Aesculap, Inc.
Cardiovascular · 60d
Cleared Apr 22, 2003
MODIFICATION TO HIOX
K030943 · CBP
Sensor Medics Corp.
Anesthesiology · 27d
Cleared Apr 21, 2003
NICOLET PIONEER TC8080
K020754 · IYN
Nicolet Biomedical
Radiology · 410d
Cleared Apr 21, 2003
LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
K030203 · MNW
Long Well Electronics Corp.
Gastroenterology & Urology · 90d
Cleared Apr 21, 2003
T-SCIENTIFIC T-PAD
K030334 · QSY
T-Scientific, Inc.
General & Plastic Surgery · 80d
Cleared Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
K030606 · GKZ
Beckman Coulter, Inc.
Hematology · 55d
Cleared Apr 21, 2003
IBD-QUIK CHEK
K030704 · DEG
Techlab, Inc.
Immunology · 46d
Cleared Apr 21, 2003
SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL
K030782 · FTM
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 41d
Cleared Apr 21, 2003
HANSON MEDICAL CALF IMPLANT
K030808 · MIB
Hanson Medical, Inc.
General & Plastic Surgery · 39d
Cleared Apr 21, 2003
HANSON MEDICAL GLUTEAL IMPLANT
K030809 · MIB
Hanson Medical, Inc.
General & Plastic Surgery · 39d
Cleared Apr 21, 2003
RITA STARBURST SDE ELECTROSURGICAL DEVICE
K030967 · GEI
Rita Medical Systems
General & Plastic Surgery · 26d
Cleared Apr 18, 2003
PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
K021421 · DRF
Tz Medical, Inc.
Cardiovascular · 350d
Cleared Apr 18, 2003
MINIPHYSIONIZER 2.0 AND ELECTRODES
K022950 · EGJ
Physion, Inc.
Physical Medicine · 225d
Cleared Apr 18, 2003
LEFORTE SYSTEM BONE SCREW
K023365 · HWC
Jeil Medical Corporation
Orthopedic · 193d
Cleared Apr 18, 2003
CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
K030231 · DWF
Sorin Group Italia S.R.L.
Cardiovascular · 86d