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
21913–21936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 2019
ALFA GATE Dental Implants System
K182143 · DZE
Alfa Gate Mazen, Ltd.
Dental · 422d
Cleared Oct 03, 2019
Asthma Monitor AM3
K183479 · BZG
Eresearch Technology
Anesthesiology · 290d
Cleared Oct 03, 2019
SAHARA Stabilization System
K190179 · OVD
K2m, Inc.
Orthopedic · 244d
Cleared Oct 03, 2019
Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe
K190208 · FFX
Diversatek Healthcare
Gastroenterology & Urology · 241d
Cleared Oct 03, 2019
CD Horizon™ Astute™ Spinal System
K191066 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Oct 03, 2019
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
K191099 · DKZ
Atlas Medical
Toxicology · 161d
Cleared CT Oct 03, 2019
XACT Robotic System
K191332 · JAK
Xact Robotics, Ltd.
Radiology · 140d
Cleared Oct 03, 2019
Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module
K191344 · HRS
Arthrex, Inc.
Orthopedic · 136d
Cleared Oct 03, 2019
Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable...
K191490 · MEG
Jiangsu Caina Medical Co.,Ltd
General Hospital · 120d
Cleared Oct 03, 2019
Vintage Art Universal
K191794 · EIH
Shofu Dental Corporation
Dental · 92d
Cleared Oct 03, 2019
Propex IQ Apex Locator
K191806 · LQY
Dentsply Sirona
Dental · 90d
Cleared Oct 03, 2019
Yumizen C1200 CRP
K191993 · DCK
HORIBA ABX SAS
Chemistry · 70d
Cleared Oct 03, 2019
Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
K192318 · LIT
Bard Peripheral Vascular, Inc.
Cardiovascular · 38d
Cleared Oct 03, 2019
Millenium HX
K192398 · FIP
Mar Cor Purification, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 03, 2019
EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG
K192400 · MQB
DRTECH Corporation
Radiology · 30d
Cleared Oct 03, 2019
Mobius3D
K192424 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Oct 03, 2019
Ablation Confirmation
K192427 · JAK
Neuwave Medical, Inc.
Radiology · 28d
Cleared Oct 02, 2019
Aimanfun Lumea Comfort
K190820 · OHT
Kam Yuen Plastic Products , Ltd.
General & Plastic Surgery · 184d
Cleared Oct 02, 2019
Neocis Planning Software Application (NPSA) for 3rd Party PCs
K191363 · PLV
Neocis, Inc.
Dental · 133d
Cleared CT Oct 02, 2019
OxySoft (olifilcon C) silicone hydrogel soft contact lens
K191397 · LPL
Visco Vision, Inc.
Ophthalmic · 131d
Cleared Oct 02, 2019
NG-Test CARBA 5
K191889 · PTJ
Ng Biotech
Microbiology · 79d
Cleared Oct 02, 2019
Momentum™ Posterior Spinal Fixation System
K191932 · NKB
Ulrich Medical USA
Orthopedic · 75d
Cleared Oct 02, 2019
LIAISON Vitamin B12
K192064 · CDD
DiaSorin, Inc.
Chemistry · 62d
Cleared Oct 01, 2019
Applied Biosystems Bacillus anthracis Detection Kit
K183462 · QIF
Mriglobal
Microbiology · 291d