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
20545–20568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 2020
G1 40 Radiopaque Bone Cement
K193059 · LOD
G21, S.R.L.
Orthopedic · 139d
Cleared Mar 19, 2020
G3 40 Radiopaque Bone Cement
K193061 · LOD
G21, S.R.L.
Orthopedic · 139d
Cleared Mar 19, 2020
restor3d Metallic Interference Screw
K193491 · HWC
Restor3d
Orthopedic · 93d
Cleared Mar 19, 2020
Deklene MAXX
K193530 · GAW
Teleflex Medical
General & Plastic Surgery · 90d
Cleared Mar 19, 2020
Super Sheath
K200379 · DRE
Togo Medikit Co., Ltd.
Cardiovascular · 30d
Cleared Mar 18, 2020
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
K191027 · BSZ
Maquet Critical Care AB
Anesthesiology · 335d
Cleared Mar 18, 2020
PulmoScan
K191876 · PNV
Cognita Labs, LLC
Anesthesiology · 247d
Cleared Mar 18, 2020
ViziShot 2 FLEX
K193517 · KTI
Olympus Surgical Technologies America
Anesthesiology · 90d
Cleared Mar 18, 2020
BioFire Blood Culture Identification 2 (BCID2) Panel
K193519 · PEN
Biofire Diagnostics, LLC
Microbiology · 90d
Cleared Mar 18, 2020
MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004...
K193536 · LTT
Beckman Coulter, Inc.
Microbiology · 89d
Cleared Mar 18, 2020
HEALICOIL Knotless Suture Anchors
K193558 · MAI
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Mar 18, 2020
Viz ICH
K193658 · QAS
Viz. Ai, Inc.
Radiology · 79d
Cleared Mar 18, 2020
speX LP Support Catheter
K200094 · DQY
Reflow Medical
Cardiovascular · 62d
Cleared Mar 18, 2020
LINK TrabecuLink Tibial Cones
K200113 · MBH
Waldemar Link GmbH & Co. KG
Orthopedic · 61d
Cleared Mar 18, 2020
WIRION
K200198 · NTE
Cardiovascular Systems, Inc.
Cardiovascular · 51d
Cleared Mar 18, 2020
Evolve Breast Pump
K200406 · HGX
Hygeia II Medical Group, Inc.
Obstetrics & Gynecology · 28d
Cleared Mar 18, 2020
VIVIX-S VW
K200418 · MQB
Vieworks Co., Ltd.
Radiology · 27d
Cleared Mar 17, 2020
Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For...
K191753 · LZA
Medline Industries, Inc.
General Hospital · 260d
Cleared Mar 17, 2020
TheraBase, TheraBase Ca
K192007 · EMA
Bisco, Inc.
Dental · 232d
Cleared Mar 17, 2020
Wolf445nm
K192272 · GEX
A.R.C Laser GmbH
General & Plastic Surgery · 208d
Cleared Mar 17, 2020
NeuralScan System
K192753 · GWQ
Medeia, Inc.
Neurology · 169d
Cleared Mar 17, 2020
myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)
K193310 · MXC
Abbott (St. Jude Medical)
Cardiovascular · 109d
Cleared Mar 17, 2020
SterilContainer S2 System
K193582 · KCT
Aesculap, Inc.
General Hospital · 85d
Cleared Mar 17, 2020
Shear Wave Quantificational Ultrasound Diagnostic System
K200136 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 56d