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
44953–44976 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 2012
WILDCAT CATHETER
K113838 · PDU
Avinger, Inc.
Cardiovascular · 75d
Cleared Mar 12, 2012
VISUAL-ICE CRYOABLATION SYSTEM
K113860 · GEH
Galil Medical, Inc.
General & Plastic Surgery · 73d
Cleared Mar 09, 2012
MICT TSH
K110761 · JLW
Magnabiosciences, LLC
Chemistry · 357d
Cleared Mar 09, 2012
HBIDB - HUMAN BRIAN INDEX SOFTWARE
K112077 · OLU
Corscience GmbH & Co. KG
Neurology · 232d
Cleared Mar 09, 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
K112638 · NBW
Nova Biomedical Corporation
Chemistry · 182d
Cleared Mar 09, 2012
SURGICAL RETRACTORS
K112659 · GCJ
Surgical Innovations Plc
General & Plastic Surgery · 178d
Cleared Mar 09, 2012
PIPELINE TOTAL HIP SYSTEM
K112802 · OQG
Pipeline Orthopedics
Orthopedic · 164d
Cleared Mar 09, 2012
MODIFIED CONCENTIRC MICROCATHETER
K113260 · DQO
Concentric Medical, Inc.
Cardiovascular · 126d
Cleared Mar 09, 2012
ASCEND SHOULDER SYSTEM
K113413 · KWS
Tornier, Inc.
Orthopedic · 112d
Cleared Mar 09, 2012
KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE
K113423 · LZA
Kimberly-Clark Corp.
General Hospital · 109d
Cleared Mar 09, 2012
HEMO-CATH 10F, HEMO-CATH 12.5F
K113487 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 09, 2012
SYNCHRONY RESPIRATORY TRACKING SYSTEM
K120233 · IYE
Accuray Incorporated
Radiology · 44d
Cleared Mar 09, 2012
SATURN 8000
K120380 · MQB
New Medical Co., Ltd.
Radiology · 31d
Cleared Mar 09, 2012
LANX SPINAL FIXATION SYSTEM
K120399 · NKB
Lanx, LLC
Orthopedic · 30d
Cleared Mar 09, 2012
QLAB QUANTIFICATION SOFTWARE
K120525 · LLZ
Philips Healthcare Group
Radiology · 16d
Cleared Mar 08, 2012
SONOVISION
K113082 · LLZ
Peridot Technologies Ny, Inc.
Radiology · 142d
Cleared Mar 08, 2012
LIASYS 450
K113131 · CFR
Ams
Chemistry · 136d
Cleared CT Mar 08, 2012
IFS LASER SYSTEM
K113151 · GEX
Abbott Medical Optics, Inc.
General & Plastic Surgery · 135d
Cleared Mar 08, 2012
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810 · PDZ
Alma Lasers, Inc.
General & Plastic Surgery · 76d
Cleared Mar 08, 2012
QUADRASPHERE 30 TO 60
K113822 · HCG
Biosphere Medical, Inc.
Neurology · 72d
Cleared Mar 08, 2012
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
K113872 · KNW
Vidacare Corporation
Gastroenterology & Urology · 69d
Cleared Mar 08, 2012
ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED
K120044 · KWS
Arthrex, Inc.
Orthopedic · 63d
Cleared Mar 08, 2012
POWER ADAPTOR INSTRUMENT ACCESSORY
K120434 · NKB
Stryker Corp.
Orthopedic · 24d
Cleared Mar 08, 2012
YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR
K120526 · IOR
Jiangsu Yuyue Medical Equipment&...
Physical Medicine · 15d