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
23305–23328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 10, 2019
S-MAK XL
K190175 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 68d
Cleared Apr 10, 2019
Confirm Rx Insertable Cardiac Monitor
K190295 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 58d
Cleared Apr 10, 2019
M.U.S.T. MINI Posterior Cervical Screws System
K190631 · NKG
Medacta International S.A.
Orthopedic · 29d
Cleared Apr 09, 2019
Transtek Blood Pressure Monitor
K181832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 274d
Cleared Apr 09, 2019
Vera
K182333 · LXJ
Reflexion Health, Inc.
Physical Medicine · 224d
Cleared Apr 09, 2019
Pantheris SV
K182341 · MCW
Avinger, Inc.
Cardiovascular · 224d
Cleared Apr 09, 2019
Adult Intraosseous Infusion Device
K182770 · FMI
Einstein Works, LLC
General Hospital · 193d
Cleared Apr 09, 2019
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
K183660 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 103d
Cleared Apr 09, 2019
ENConnect 40 mm Screw Cap to ENPlus Adapter
K190327 · PIF
Cedic S.R.L.
Gastroenterology & Urology · 55d
Cleared Apr 09, 2019
ExcelsiusGPS
K190653 · OLO
Globus Medical, Inc.
Orthopedic · 26d
Cleared Apr 08, 2019
CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®
K182375 · NKB
Globus Medical, Inc.
Orthopedic · 220d
Cleared Apr 08, 2019
Bone VCAR (BVCAR)
K183204 · JAK
GE Medical Systems SCS
Radiology · 140d
Cleared Apr 08, 2019
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD...
K183496 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 112d
Cleared Apr 08, 2019
Ergoline Sunrise 7200 Hybrid Technology
K183539 · LEJ
Jk Holding GmbH
General & Plastic Surgery · 109d
Cleared Apr 08, 2019
Vitality® Spinal Fixation System
K183550 · NKB
Zimmer Biomet Spine, Inc.
Orthopedic · 109d
Cleared Apr 08, 2019
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
K183606 · IYE
Scandidos AB
Radiology · 103d
Cleared Apr 08, 2019
OIC External Fixation System
K183682 · KTT
Orthopaedic Implant Company
Orthopedic · 101d
Cleared Apr 08, 2019
Straumann BLX Line Extension - New Abutments
K190040 · NHA
Institut Straumann AG
Dental · 90d
Cleared Apr 08, 2019
VIVIX-S 1751S
K190611 · MQB
Vieworks Co., Ltd.
Radiology · 28d
Cleared Apr 06, 2019
MEDINAUT Plus
K182287 · HRX
Imedicom Co., Ltd.
Orthopedic · 226d
Cleared Apr 05, 2019
OJR215 Pressure Relief Manifold
K173770 · CBP
Fisher & Paykel Healthcare Limited
Anesthesiology · 480d
Cleared Apr 05, 2019
Patient Monitor
K181919 · MWI
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 261d
Cleared Apr 05, 2019
TCD-X
K182175 · IYN
Atys
Radiology · 238d
Cleared Apr 05, 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268 · FMF
Flat Medical Co., Ltd.
General Hospital · 227d