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
20713–20736 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 2020
icobrain-ctp
K192962 · LLZ
Icometrix NV
Radiology · 129d
Cleared Feb 28, 2020
CONQUEST FN
K193029 · JDO
Smith & Nephew, Inc.
Orthopedic · 121d
Cleared Feb 28, 2020
Alta Multipurpose Device
K193243 · IYE
Qfix
Radiology · 95d
Cleared Feb 28, 2020
Cellvizio I.V.E. with Confocal Miniprobes
K193416 · OWN
Mauna Kea Technologies
General & Plastic Surgery · 81d
Cleared Feb 28, 2020
Basal-IQ Technology
K193483 · QJS
Tandem Diabetes Care, Inc.
Chemistry · 73d
Cleared Feb 28, 2020
Therm-X
K193550 · IRP
Zenith Technical Innovations
Physical Medicine · 70d
Cleared Feb 28, 2020
CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid...
K200221 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 30d
Cleared Feb 28, 2020
Arctic Sun Stat Temperature Management System
K200225 · DWJ
Medivance, Inc.
Cardiovascular · 29d
Cleared Feb 28, 2020
R-Sensor, R-Sensor
K200284 · MUH
Remedi Co., Ltd.
Radiology · 23d
Cleared Feb 28, 2020
Daytona® Small Stature Spinal System
K200381 · NKB
SeaSpine Orthopedics Corporation
Orthopedic · 10d
Cleared Feb 27, 2020
Disposable Sclerotherapy Needle
K190032 · FBK
Hangzhou AGS MedTech Co., Ltd.
Gastroenterology & Urology · 416d
Cleared Feb 27, 2020
Explorer Mini
K190682 · IPL
Permobil AB
Physical Medicine · 346d
Cleared Feb 27, 2020
ST Internal Implant System
K190919 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 324d
Cleared Feb 27, 2020
Proov Test
K191462 · QKE
Mfb Fertility, Inc.
Chemistry · 269d
Cleared Feb 27, 2020
Penumbra System Penumbra JET 7X
K191946 · NRY
Penumbra, Inc.
Neurology · 220d
Cleared Feb 27, 2020
Omnia Medical Trauma Screws
K192096 · HWC
Omnia Medical, LLC
Orthopedic · 206d
Cleared Feb 27, 2020
Colibri Endoscopy System
K192305 · EOB
3nt Medical , Ltd.
Ear, Nose, Throat · 188d
Cleared Feb 27, 2020
Pitkar Locked Plating System
K192619 · HRS
S.H.Pitkar Orthotools Pvt. , Ltd.
Orthopedic · 157d
Cleared Feb 27, 2020
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
K192683 · LZO
Biomet UK, Ltd.
Orthopedic · 154d
Cleared Feb 27, 2020
CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA...
K192804 · QJP
Medos International SARL
Neurology · 149d
Cleared Feb 27, 2020
INTELLIO Tablet Application
K192876 · ODA
Smith & Nephew
General & Plastic Surgery · 142d
Cleared Feb 27, 2020
Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse...
K193242 · MWI
Masimo Corporation
Anesthesiology · 94d
Cleared Feb 27, 2020
APrioCore Plus
K193268 · KNW
Apriomed AB
General & Plastic Surgery · 93d
Cleared Feb 27, 2020
Rodo Abutment System
K193274 · NHA
Rodo Medical, Inc.
Dental · 93d