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

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175,820 results
32377–32400 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 2016
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear,...
K153766 · LPL
INTEROJO, Inc.
Ophthalmic · 100d
Cleared Apr 08, 2016
RayStation
K160093 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 80d
Cleared Apr 08, 2016
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic...
K160223 · NHC
Cook Incorporated
Neurology · 70d
Cleared Apr 08, 2016
ICONACY(TM) I-Hip(TM)
K160266 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 66d
Cleared Apr 08, 2016
geko(TM) Plus R-2 Neuromuscular Stimulator
K160299 · IPF
Firstkind Limited
Physical Medicine · 64d
Cleared Apr 08, 2016
spineEOS
K160407 · LLZ
Onefit Medical
Radiology · 52d
Cleared Apr 08, 2016
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software
K160579 · LLZ
Rayence Co., Ltd.
Radiology · 38d
Cleared Apr 07, 2016
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test
K142754 · LCX
Sugentech, Inc.
Chemistry · 560d
Cleared Apr 07, 2016
transGlide Expandable Introducer
K152194 · DYB
Transaortic Medical, Inc.
Cardiovascular · 246d
Cleared Apr 07, 2016
U2 Bipolar Implant and 22mm Femoral Head
K152439 · KWY
United Orthopedic Corporation
Orthopedic · 224d
Cleared Apr 07, 2016
StrataMR Valves and Shunts
K152700 · JXG
Medtronic Neurosurgery
Neurology · 199d
Cleared Apr 07, 2016
Merge Hemo
K152864 · DQK
Merge Healthcare Incorporated
Cardiovascular · 190d
Cleared Apr 07, 2016
FIRMap Catheter
K153093 · MTD
Abbott Electrophysiology
Cardiovascular · 164d
Cleared Apr 07, 2016
ReGrasp
K153163 · GZI
Rehabtronics, Inc.
Neurology · 157d
Cleared Apr 07, 2016
EM ENT Navigated Suctions
K153555 · PGW
Medtronic Navigation, Inc.
Ear, Nose, Throat · 115d
Cleared Apr 07, 2016
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner
K160343 · IYN
Beijing East Whale Imaging Technology...
Radiology · 59d
Cleared Apr 07, 2016
CX50N, CX50YQS
K160351 · PGY
Wide Corporation
Radiology · 59d
Cleared Apr 07, 2016
CX20N(CX20PUX)
K160355 · PGY
Wide Corporation
Radiology · 59d
Cleared Apr 07, 2016
BD FlowSmart Set, MiniMed Pro-Set
K160651 · FPA
Becton, Dickinson and Company
General Hospital · 30d
Cleared Apr 07, 2016
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)
K160659 · MOF
Asahi Intecc Co., Ltd.
Neurology · 30d
Cleared Apr 06, 2016
KLS Martin LSS Plating System
K151983 · JDQ
KLS-Martin L.P.
Orthopedic · 264d
Cleared Apr 06, 2016
Extension Set
K153293 · FPA
B.Braun Medical, Inc.
General Hospital · 145d
Cleared Apr 06, 2016
KLS Martin Thoracic Plating System
K153482 · HRS
KLS-Martin L.P.
Orthopedic · 125d
Cleared Apr 06, 2016
Magma System
K153566 · GEX
Formatk Systems , Ltd.
General & Plastic Surgery · 114d