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
70513–70536 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 19, 2003
REVOLUTION SPINAL FIXATION SYSTEM
K032219 · MNI
Spinal Innovations, Inc.
Orthopedic · 151d
Cleared Dec 19, 2003
IMMUNETECH TOTAL IGE SYSTEM
K032251 · DGC
Immunetech Corporation
Immunology · 150d
Cleared Dec 19, 2003
VITOSS SCAFFOLD FOAM BONE GRAFT MATERIAL
K032288 · MQV
Orthovita, Inc.
Orthopedic · 148d
Cleared Dec 19, 2003
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH...
K032663 · DCK
Instrumentation Laboratory CO
Chemistry · 113d
Cleared Dec 19, 2003
VASCULAR SOLUTIONS PRONTO EXTRACTION CATHETER
K032763 · QEZ
Vascular Solutions, Inc.
Cardiovascular · 105d
Cleared Dec 19, 2003
PHENOL RED STOCK SOLUTION
K032887 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 94d
Cleared Dec 19, 2003
SHELHIGH NO-REACT BIOCUFF
K032893 · FTL
Shelhigh, Inc.
General & Plastic Surgery · 93d
Cleared Dec 19, 2003
MEDIPHYSICS PAIN TREATMENT SYSTEM, MODEL 1
K032928 · GZJ
Mediphysics Pain Centers of America
Neurology · 88d
Cleared Dec 19, 2003
YA-MAN LASER 21
K032944 · GEX
Ya-Man, Ltd.
General & Plastic Surgery · 88d
Cleared Dec 19, 2003
GEM INSET PATELLAR COMPONENT
K032950 · JWH
Kinamed, Inc.
Orthopedic · 88d
Cleared Dec 19, 2003
IMPAK ACRYLIC REPAIR RESIN LIQUID
K033020 · EBI
Cmp Industries, LLC
Dental · 84d
Cleared Dec 19, 2003
LIFESTYLES LIQUID PERSONAL LUBRICANT
K033076 · HIS
Ansell Healthcare, Inc.
Obstetrics & Gynecology · 81d
Cleared Dec 19, 2003
WALLACE (SURE VIEW) EMBRYO REPLACEMENT CATHETER AND TRIAL TRANSFER CATHETER
K033084 · MQF
Portex , Ltd.
Obstetrics & Gynecology · 81d
Cleared Dec 19, 2003
ECSTASY ENZYME IMMUNOASSAY, CATALOG # 0160 (500 TEST KIT), CATALOG # 0161...
K033094 · DKZ
Lin-Zhi International, Inc.
Toxicology · 81d
Cleared Dec 19, 2003
LEMAITRE VASCULAR STRAIGHT CAROTID SHUNT, MODEL 2002-01, 2002-05, 2003-01,...
K033159 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 80d
Cleared Dec 19, 2003
WILSON-COOK TRI-TOME SELECT PLUS
K033203 · KNS
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 19, 2003
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · JDC
Biomet, Inc.
Orthopedic · 70d
Cleared Dec 19, 2003
EXACTRAC GATING
K033287 · IYE
Brainlab AG
Radiology · 66d
Cleared Dec 19, 2003
DEGALL II GALLBLADDER EXTRACTOR
K033359 · GCJ
Surgicon, Inc.
General & Plastic Surgery · 59d
Cleared Dec 19, 2003
BAYER SPECIAL CHEMISTRY CONTROLS
K033379 · JJY
Bayer Diagnostics Corp.
Chemistry · 58d
Cleared Dec 19, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64...
K033558 · LON
Becton, Dickinson & CO
Microbiology · 37d
Cleared Dec 19, 2003
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS,...
K033603 · LIG
Beckman Coulter, Inc.
Chemistry · 32d
Cleared Dec 19, 2003
MOBILE EXTERNAL COUNTER PULSATION SYSTEM ANGIONEW-V
K033657 · DRN
Living Data Technologies Corporation
Cardiovascular · 28d
Cleared Dec 19, 2003
SAFYRE VS AND SAFYRE T
K033691 · OTN
Promedon
Gastroenterology & Urology · 25d