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
71329–71352 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 06, 2003
MODIFICATION TO RENEW LEAD EXTENSION
K032751 · GZB
Advanced Neuromodulation Systems
Neurology · 31d
Cleared Oct 06, 2003
EXTERNAL DRAINAGE SET
K032817 · JXG
Integra Neurosciences Implants S.A.
Neurology · 26d
Cleared Oct 06, 2003
C.T.M. MOBILITY SCOOTER, MODEL HS-235
K032918 · INI
C.T.M. Homecare Product, Inc.
Physical Medicine · 14d
Cleared Oct 03, 2003
REPROCESSED ELECTROPHYSIOLOGY CATHETER
K030279 · NLH
Alliance Medical Corp.
Cardiovascular · 249d
Cleared Oct 03, 2003
EPSILON DURASUL CONSTRAINED ACETABULAR LINER
K030923 · KWZ
Centerpulse Orthopedics, Inc.
Orthopedic · 193d
Cleared Oct 03, 2003
ANS AXXESS PERCUTANEOUS LEAD
K032034 · GZB
Advanced Neuromodulation Systems
Neurology · 94d
Cleared Oct 03, 2003
MEDS-4-INF+
K032055 · GZJ
Medical Equipment Device Specialists
Neurology · 93d
Cleared Oct 03, 2003
SONOSURG SYSTEM
K032066 · LFL
The Olympus Optical Co.
General & Plastic Surgery · 92d
Cleared Oct 03, 2003
GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000
K032085 · GEX
Nidek, Inc.
General & Plastic Surgery · 88d
Cleared Oct 03, 2003
ELAN DIGITAL 12 CHANNEL ELECTROCARDIOGRAPH
K032200 · DPS
Remco Italia S.P.A.
Cardiovascular · 77d
Cleared Oct 03, 2003
MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100...
K032231 · ILY
Medx Electronics, Inc.
Physical Medicine · 74d
Cleared Oct 03, 2003
PLACER
K032349 · GZB
Advanced Neuromodulation Systems
Neurology · 95d
Cleared Oct 03, 2003
ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221
K032461 · DIC
Lin-Zhi International, Inc.
Toxicology · 53d
Cleared Oct 03, 2003
DISPOSABLE POWDER FREE VINYL EXAM GLOVES
K032630 · LYZ
Kingswell International, Inc.
General Hospital · 38d
Cleared Oct 03, 2003
VIVATIP MICROWAVE ABLATION PROBE
K032702 · GEI
Vivant Medical, Inc.
General & Plastic Surgery · 31d
Cleared Oct 03, 2003
MOSFET AUTOSENSE WIRELESS
K032725 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 30d
Cleared Oct 03, 2003
HEART 2006
K032736 · DXH
Aerotel Medical Systems (1998) , Ltd.
Cardiovascular · 29d
Cleared Oct 03, 2003
VACURECT VACUUM CONSTRICTION DEVICE
K032776 · LKY
Vacurect Manufacturing (Pty) , Ltd.
Gastroenterology & Urology · 25d
Cleared Oct 02, 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439 · ELW
Harry J. Bosworth Co.
Dental · 149d
Cleared Oct 02, 2003
3D INVIVO BY CSIST
K031567 · LLZ
Chung-Shan Institute of Science and...
Radiology · 136d
Cleared Oct 02, 2003
SECTRA ORTHOPEDIC PACKAGE
K031590 · LLZ
Sectra-Imtec AB
Radiology · 134d
Cleared Oct 02, 2003
AQUABOSS ECORO DIA 50
K032004 · FIP
Lauer Ltd., Hong Kong
Gastroenterology & Urology · 94d
Cleared Oct 02, 2003
HLS NOETOS SYSTEM
K032079 · JWH
Tornier
Orthopedic · 87d
Cleared Oct 02, 2003
I-BEAM
K032100 · IYE
Computerized Medical Systems, Inc.
Radiology · 86d