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
19873–19896 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 10, 2020
Naviswiss Hip Navigation System
K193094 · OLO
Naviswiss AG
Orthopedic · 216d
Cleared Jun 10, 2020
BruxZir Steel
K200131 · EIH
Prismatik Dentalcraft, Inc.
Dental · 141d
Cleared Jun 10, 2020
RayCare 3.1
K200487 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 104d
Cleared Jun 10, 2020
SeaSpine Meridian System, SeaSpine Regatta Lateral System
K200879 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 69d
Cleared Jun 10, 2020
Hemospray Endoscopic Hemostat
K200972 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jun 10, 2020
SR-8230, SR-8230S Portable X-ray Unit
K200976 · IZL
Shantou Institute of Ultrasonic...
Radiology · 58d
Cleared Jun 10, 2020
Intraoral Sensor
K201247 · MQB
Dentium Co., Ltd (Ict Branch)
Radiology · 30d
Cleared Jun 10, 2020
TSolution® One Total Knee Application
K201255 · OLO
THINK Surgical, Inc.
Orthopedic · 30d
Cleared Jun 09, 2020
ImmersiveView Surgical Plan (IVSP®)
K181813 · DZJ
Immersivetouch
Dental · 704d
Cleared Jun 09, 2020
Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour...
K192033 · DZI
Bennett Jacoby, Dds, Ms, Inc.
Dental · 315d
Cleared Jun 09, 2020
Osteo3 ZP Putty
K193075 · MQV
Sirakoss , Ltd.
Orthopedic · 218d
Cleared Jun 09, 2020
CO2 Laser System
K200042 · GEX
Beijing Superlaser Technology Co., Ltd.
General & Plastic Surgery · 153d
Cleared Jun 09, 2020
IBS Implant System II
K200753 · NHA
Innobiosurg Co., Ltd.
Dental · 78d
Cleared Jun 09, 2020
Venus Epileve
K200786 · GEX
Venus Concept USA, Inc.
General & Plastic Surgery · 75d
Cleared Jun 09, 2020
DANNIK Disposable Monopolar Laparoscopic Instrument
K201063 · GEI
Dannik
General & Plastic Surgery · 49d
Cleared Jun 08, 2020
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the...
K193067 · HSN
Wrightmedicaltechnologyinc
Orthopedic · 217d
Cleared Jun 08, 2020
Air Compression Therapy Device
K193354 · IRP
Shenzhen Dongjilian Electronics Co.,...
Physical Medicine · 187d
Cleared Jun 08, 2020
ePM Series Patient monitors
K200015 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 157d
Cleared Jun 06, 2020
mCare(R) Powder Free Nitrile Orange Examination Gloves
K200967 · LZA
Mercator Medical (Thailand), Ltd.
General Hospital · 57d
Cleared Jun 05, 2020
Exofin Fusion Skin Closure System
K191461 · OMD
Chemence Medical, Inc.
General & Plastic Surgery · 368d
Cleared Jun 05, 2020
EZ-Cover
K191491 · ITX
Medxpress.Pro
Radiology · 366d
Cleared Jun 05, 2020
3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM...
K192550 · FRC
3M Company
General Hospital · 262d
Cleared Jun 05, 2020
Spire Health Remote Patient Monitoring System
K192952 · MSX
Spire, Inc. D/B/A Spire Health
Cardiovascular · 228d
Cleared Jun 05, 2020
VivaChek Blood Glucose and B-Ketone Monitoring System
K192957 · JIN
Vivachek Biotech (Hangzhou) Co., Ltd.
Chemistry · 228d