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
26977–27000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 12, 2018
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN...
K172774 · HSB
Stryker Trauma GmbH
Orthopedic · 120d
Cleared Jan 12, 2018
cobas Factor II and Factor V Test
K172913 · NPR
Roche Molecular Systems, Inc.
Hematology · 109d
Cleared Jan 12, 2018
6440 Ultrasound System
K173291 · IYN
Esaote, S.P.A.
Radiology · 88d
Cleared Jan 12, 2018
K-Y Silicone
K173504 · NUC
Reckitt Benckiser, LLC
Obstetrics & Gynecology · 60d
Cleared Jan 12, 2018
ImagenUniversal
K173547 · KPS
Cardiovascular Imaging Technologies
Radiology · 57d
Cleared Jan 12, 2018
Microcatheter
K173560 · DQY
Surmodics,Inc.
Cardiovascular · 56d
Cleared Jan 12, 2018
Illumeo System
K173588 · LLZ
Philips Medical Systems Technologies...
Radiology · 53d
Cleared Jan 12, 2018
Optima XR240amx, AutoGrid
K173602 · IZL
Ge Medical Systems, LLC
Radiology · 52d
Cleared Jan 12, 2018
syngo.via RT Image Suite
K173635 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Jan 12, 2018
GU60A & GU60A-65
K173828 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Jan 11, 2018
ET Hybrid Abutment
K170421 · NHA
Hiossen, Inc.
Dental · 332d
Cleared Jan 11, 2018
GLOBAL UNITE Platform Shoulder System
K170748 · PHX
Depuy Ireland UC
Orthopedic · 307d
Cleared Jan 11, 2018
CEREC Ortho Software
K171122 · PNN
Dentsply Sirona
Dental · 269d
Cleared Jan 11, 2018
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M
K171207 · ODG
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 261d
Cleared Jan 11, 2018
Digital Electrocardiograph
K171517 · DPS
Biocare Bio-Medical Equipment Co., Ltd.
Cardiovascular · 232d
Cleared Jan 11, 2018
Dentium Ti-Base
K171622 · NHA
Dentium Co., Ltd.
Dental · 223d
Cleared Jan 11, 2018
Microcatheter and guide-wire system
K171665 · KRA
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 220d
Cleared Jan 11, 2018
ECHELON OVAL V6.0A MRI System
K172110 · LNH
Hitachi Healthcare Americas Corporation
Radiology · 182d
Cleared Jan 11, 2018
HYDRASHIFT 2/4 daratumumab, daratumumab Control
K172195 · CFF
Sebia
Immunology · 174d
Cleared Jan 11, 2018
ExoToe Staple
K172205 · JDR
Exotoe, LLC
Orthopedic · 174d
Cleared Jan 11, 2018
DTX Studio diagnose
K172224 · LLZ
Nobel Biocare AB
Radiology · 170d
Cleared Jan 11, 2018
Bruxor
K172452 · OBR
Sleep Specialties, LLC
Dental · 150d
Cleared Jan 11, 2018
Automated ankle brachial pressure index measuring device
K172655 · JOM
Mesi D.O.O.; Mesi, Development of...
Cardiovascular · 128d