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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
41617–41640 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2013
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
K123943 · MSD
Ameco Medical Industries
Gastroenterology & Urology · 103d
Cleared Apr 02, 2013
TANDA MINI SKINCARE SYSTEM
K124042 · OLP
Syneron Beauty
General & Plastic Surgery · 95d
Cleared Apr 02, 2013
THERMOFINDER
K130361 · FLL
Hubdic Co., Ltd.
General Hospital · 48d
Cleared Apr 02, 2013
EXCELSIOR
K130453 · NFJ
Eyekor, LLC
Ophthalmic · 39d
Cleared Apr 02, 2013
BD MAX CDIFF ASSAY, BD MAX INSTRUMENT
K130470 · OZN
Geneohm Sciences Canada, Inc. (Bd...
Microbiology · 36d
Cleared Apr 02, 2013
CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
K130576 · LJT
B. Braun Interventional Systems, Inc.
General Hospital · 28d
Cleared Apr 01, 2013
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
K120056 · DFH
The Binding Site Group , Ltd.
Immunology · 448d
Cleared Apr 01, 2013
NEUROBLATE SYSTEM
K120561 · GEX
Monteris Medical, Inc.
General & Plastic Surgery · 402d
Cleared Apr 01, 2013
NMI COAXIAL MICROINTRODUCER SET
K123445 · DRE
Navilyst Medical, Inc.
Cardiovascular · 144d
Cleared Apr 01, 2013
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
K123733 · OCL
Medtronic, Inc.
Cardiovascular · 117d
Cleared Apr 01, 2013
IFUSE IMPLANT SYSTEM
K123850 · OUR
SI-BONE, Inc.
Orthopedic · 108d
Cleared Apr 01, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
Cleared Apr 01, 2013
INFINITY TOTAL ANKLE SYSTEM
K123954 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 101d
Cleared Apr 01, 2013
WALKAIDE SYSTEM
K123972 · GZI
Innovative Neurotronics, Inc.
Neurology · 96d
Cleared Apr 01, 2013
TRANS1LATERAL INTERBODY FUSION SYSTEM
K123997 · MAX
Trans1, Inc.
Orthopedic · 96d
Cleared Apr 01, 2013
STREAMLINE MIS SPINAL FIXATION SYSTEM
K130286 · NKB
Pioneer Surgical Technology, Inc.
Orthopedic · 55d
Cleared Apr 01, 2013
SPIDER SYSTEM KOLIBRI CEMENT NEEDLE
K130402 · NDN
Sintea Plustek, LLC
Orthopedic · 41d
Cleared Mar 29, 2013
NEXUS IR30 NON-CONTACT INFRARED FOREHEAD THERMOMETER
K122221 · FLL
Taidoc Technology Corporation
General Hospital · 247d
Cleared Mar 29, 2013
AEI DR. TERAUCHI ULTRASONIC TIPS
K122501 · ELC
American Eagle Instruments, Inc.
Dental · 225d
Cleared Mar 29, 2013
LITECURE THERAPY SYSTEM MODEL LTS-1500
K123014 · PDZ
Litecure, LLC
General & Plastic Surgery · 183d
Cleared Mar 29, 2013
CELLULAZE LASER
K123407 · OYW
Cynosure, Inc.
General & Plastic Surgery · 144d
Cleared Mar 29, 2013
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON...
K123484 · LPL
St. shine Optical Co., Ltd.
Ophthalmic · 136d
Cleared Mar 29, 2013
SCENARIA PHASE 2 WHOLE-BODY X-RAY CT SYSTEM
K123509 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 136d
Cleared Mar 29, 2013
FLOWER SMALL AND MEDIUM BONE IMPLANTS
K123562 · HRS
Flower Orthopedics Corporation
Orthopedic · 130d