FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

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175,820 results
26305–26328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 30, 2018
Performer Guiding Sheath
K171988 · DYB
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 30, 2018
Mandril Wire Guide
K171997 · DQX
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 30, 2018
ImmuLisa Enhanced RNA POL III Antibody ELISA
K172078 · NYO
Immco Diagnostics, Inc.
Immunology · 263d
Cleared Mar 30, 2018
OLYMPUS URF-V2/V2R
K172246 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 247d
Cleared Mar 30, 2018
eego amplifiers
K172312 · GWL
Eemagine Medical Imaging Solutions GmbH
Neurology · 241d
Cleared Mar 30, 2018
Bleep DreamPort
K172335 · BZD
Snapcpap
Anesthesiology · 240d
Cleared Mar 30, 2018
Nipro Syringe
K173029 · FMF
Nipro Medical Corporation
General Hospital · 183d
Cleared Mar 30, 2018
Straumann Variobase for Crown AS
K173379 · NHA
Institut Straumann AG
Dental · 151d
Cleared Mar 30, 2018
RADspeed fit
K173517 · KPR
Shimadzu Corporation
Radiology · 136d
Cleared Mar 30, 2018
Merit Pursue Microcatheter
K173548 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 134d
Cleared Mar 30, 2018
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
K173617 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 30, 2018
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition...
K173630 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 126d
Cleared Mar 30, 2018
syngo.CT Coronary Analysis
K173637 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 126d
Cleared Mar 30, 2018
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
K173789 · IWB
Elekta Instrument AB
Radiology · 106d
Cleared Mar 30, 2018
SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
K180194 · MSB
Paragonix Technologies, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 30, 2018
Vitrea Software Package
K180323 · LLZ
Canon Medical Systems Corporation
Radiology · 53d
Cleared Mar 30, 2018
gammaCore Sapphire
K180538 · PKR
Electrocore, LLC
Neurology · 30d
Cleared Mar 30, 2018
G-scan Brio
K180592 · LNH
Esaote, S.P.A.
Radiology · 24d
Cleared Mar 29, 2018
IXOS Radius Plate System
K171624 · HRS
Stuckenbrock Medizintechnik GmbH
Orthopedic · 300d
Cleared Mar 29, 2018
Arthrex Shoulder System
K171841 · KWS
Arthrex, Inc.
Orthopedic · 282d
Cleared Mar 29, 2018
Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo...
K172071 · DTZ
Terumo Cardiovascular Systems...
Cardiovascular · 262d
Cleared Mar 29, 2018
OLYMPUS URF-P6/P6R
K172298 · FGB
Olympus Medical Systems Corp.
Gastroenterology & Urology · 241d
Cleared Mar 29, 2018
Atellica IM Total hCG (ThCG)
K172322 · JHI
Siemens Healthcare Diagnostics, Inc.
Chemistry · 240d
Cleared Mar 29, 2018
TwitchView System
K172843 · KOI
Blink Device Corporation
Anesthesiology · 191d