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
39793–39816 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 2013
SPECTRUM SPINE SPINOUS PROCESS DEVICE
K130066 · PEK
Spectrum Spine IP Holdings, LLC
Orthopedic · 306d
Cleared Nov 12, 2013
SHANGHAI PHOENIX MECHANICAL WHEELCHAIR
K130848 · IOR
Shanghai Phoenix Medical Equipment...
Physical Medicine · 231d
Cleared Nov 12, 2013
NON-CONTACT INFRARED THERMOMETER
K131243 · FLL
Shenzhen Jumper Medical Equipment...
General Hospital · 195d
Cleared Nov 12, 2013
ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM
K132085 · LCX
Co-Innovation Biotech Co., Ltd.
Chemistry · 130d
Cleared Nov 12, 2013
BECE CAD ZIRKON HT+
K132102 · EIH
Bego Bremer Goldschlaegerei Wilh....
Dental · 127d
Cleared Nov 12, 2013
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
K132106 · JAA
Toshiba America Medical Systems, In.C
Radiology · 127d
Cleared Nov 12, 2013
STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML,...
K132276 · KPE
Hospira, Inc.
General Hospital · 113d
Cleared Nov 12, 2013
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
K132294 · KPR
Radiology Solutions, LLC
Radiology · 112d
Cleared Nov 12, 2013
BIOGRAPH MMR
K133226 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Nov 12, 2013
QUADROX-IR ADULT AND SMALL ADULT
K133265 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 20d
Cleared Nov 09, 2013
HUMELOCK II CEMENTLESS SHOULDER SYSTEM
K130759 · HSD
Fx Solutions
Orthopedic · 234d
Cleared Nov 09, 2013
CAYMAN MI PLATE SYSTEM
K131533 · KWQ
K2m, Inc.
Orthopedic · 168d
Cleared Nov 08, 2013
K-Y BRAND LIQUIBEADS
K122061 · NUC
Johnson & Johnson Healthcare Products
Obstetrics & Gynecology · 483d
Cleared Nov 08, 2013
BYTECH
K130101 · LYZ
Bytech Dongtai Co., Ltd.
General Hospital · 297d
Cleared Nov 08, 2013
ORTHOALIGN PLUS SYSTEM
K130387 · OLO
Orthalign, Inc.
Orthopedic · 266d
Cleared Nov 08, 2013
MICROSCAN DRIED GRAM-POSTIVE MIC/COMBO PANELS
K131275 · LTT
Siemens Helathcare Diagnostics, Inc.
Microbiology · 189d
Cleared Nov 08, 2013
ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
K131767 · ONN
Orthosensor, Inc.
Orthopedic · 144d
Cleared Nov 08, 2013
APNEALINK PRO
K131932 · MNR
Resmed Germany, Inc.
Anesthesiology · 134d
Cleared Nov 08, 2013
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS
K132515 · CEW
DiaSorin, Inc.
Chemistry · 88d
Cleared Nov 08, 2013
MEDIVALVE ACWIRE
K132545 · DQX
Medivalve , Ltd.
Cardiovascular · 87d
Cleared Nov 08, 2013
PASS LP SPINAL SYSTEM
K132574 · OSH
Medicrea International
Orthopedic · 84d
Cleared Nov 08, 2013
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
K132913 · IYN
Ge Healthcare
Radiology · 52d
Cleared Nov 07, 2013
UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST,...
K131236 · LCX
Ucp Biosciences, Inc.
Chemistry · 190d
Cleared Nov 07, 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240 · LXB
Cochlear Americas
Ear, Nose, Throat · 190d