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
30265–30288 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 23, 2016
Zilver 635 Biliary Stent
K163018 · FGE
Cook Ireland, Ltd.
Gastroenterology & Urology · 53d
Cleared Dec 23, 2016
Reprocessed Kendall SCD Express Foot Cuff
K163055 · JOW
Covidien
Cardiovascular · 52d
Cleared Dec 23, 2016
Ez3D-i / E3
K163539 · LLZ
Ewoosoft Co., Ltd.
Radiology · 7d
Cleared Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test...
K151545 · CHH
Polymer Technology Systems, Inc.
Chemistry · 562d
Cleared Dec 22, 2016
Neurosoft TMS
K160309 · OBP
Teleemg, LLC
Neurology · 322d
Cleared Dec 22, 2016
Sysmex XN-L Automated Hematology Analyzer
K160538 · GKZ
Sysmex America, Inc.
Hematology · 300d
Cleared Dec 22, 2016
XN CAL
K160585 · KRX
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN-L CHECK
K160586 · JPK
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK BF
K160588 · JPK
Streck
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK
K160590 · JPK
Streck
Hematology · 296d
Cleared Dec 22, 2016
VPS Rhythm Device with TipTracker Technology
K160925 · LJS
Arrow International, Inc. (A...
General Hospital · 262d
Cleared Dec 22, 2016
Go Dose System
K160949 · NDC
Eli Lilly and Company
General Hospital · 261d
Cleared Dec 22, 2016
Patient Monitor
K160981 · MHX
Edan Instruments, Inc.
Cardiovascular · 259d
Cleared Dec 22, 2016
Sphynx™
K160982 · KWQ
Eden Spine, LLC
Orthopedic · 259d
Cleared Dec 22, 2016
neon3™ universal OCT spinal stabilization
K161032 · NKG
Ulrich GmbH & Co. KG
Orthopedic · 253d
Cleared Dec 22, 2016
The Small PLATEAU (PLATEAU-C) Spacer System
K161127 · ODP
Life Spine, Inc.
Orthopedic · 245d
Cleared Dec 22, 2016
Neocis Guidance System
K161399 · PLV
Neocis, Inc.
Dental · 216d
Cleared Dec 22, 2016
HydraGuard 10 UltraFilter
K161467 · NHV
Nephros, Inc.
Gastroenterology & Urology · 209d
Cleared Dec 22, 2016
DynaMesh-VENTRAL
K161550 · FTL
Feg Textiltechnik Forschungs- Und...
General & Plastic Surgery · 202d
Cleared Dec 22, 2016
Y-MIC
K161639 · ELC
Micron Corporation
Dental · 191d
Cleared Dec 22, 2016
Collagentex Rx-1
K162022 · NHN
Tanses Technologies, Inc.
Physical Medicine · 154d
Cleared Dec 22, 2016
CardioChek Plus Test System, CardioChek Home Test System
K162282 · CGA
Polymer Technology Systems, Inc....
Chemistry · 129d
Cleared Dec 22, 2016
derma+flex QS High Viscosity Tissue Adhesive
K162352 · MPN
Chemence Medical, Inc.
General & Plastic Surgery · 121d
Cleared Dec 22, 2016
FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System,...
K162446 · MAX
Orthofix, Inc.
Orthopedic · 112d