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
22585–22608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 12, 2019
iNtuition-Structural Heart Module
K191585 · LLZ
Terarecon,Inc.
Radiology · 28d
Cleared Jul 12, 2019
Valleylab FT10 Electrosurgical Platform
K191601 · GEI
Covidien
General & Plastic Surgery · 25d
Cleared Jul 11, 2019
ScopeFlow Pure(TM)
K181418 · OCX
Partnership Medical Limited
Gastroenterology & Urology · 406d
Cleared Jul 11, 2019
EndoStream(TM)
K181457 · OCX
Partnership Medical Limited
Gastroenterology & Urology · 402d
Cleared Jul 11, 2019
GC FujiCEM 2 (Improved)
K182854 · EMA
GC America, Inc.
Dental · 274d
Cleared Jul 11, 2019
Stryker PEEK Customized Cranial Implant Kit
K190229 · GWO
Stryker
Neurology · 156d
Cleared Jul 11, 2019
Unifi Workspace v1.0.0
K190694 · LLZ
Hologic, Inc.
Radiology · 115d
Cleared Jul 11, 2019
Zygomatic Implants
K190718 · DZE
Jjgc Industria E Comercio DE...
Dental · 113d
Cleared Jul 11, 2019
Nalu Lead Blank (50cm)
K190960 · GZB
Boston Scientific Neuromodulation
Neurology · 90d
Cleared Jul 11, 2019
AeroForm Tissue Expander, Smooth
K191138 · PQN
Airxpanders, Inc.
General & Plastic Surgery · 72d
Cleared Jul 11, 2019
Senhance Surgical System
K191482 · NAY
Transenterix, Inc.
General & Plastic Surgery · 37d
Cleared Jul 11, 2019
ID NOW Influenza A & B 2
K191534 · OCC
Abbott Diagnostics Scarborough, Inc.
Microbiology · 31d
Cleared Jul 11, 2019
Voyant System
K191579 · HRX
Viseon, Inc.
General & Plastic Surgery · 27d
Cleared Jul 11, 2019
Nuvis Battery Arthroscope
K191594 · HRX
Integrated Endoscopy, Inc.
General & Plastic Surgery · 24d
Cleared Jul 10, 2019
Scooter
K182471 · INI
Tianjin Kepler Vehicle Industry Co. ,...
Physical Medicine · 303d
Cleared Jul 10, 2019
Scepter Mini Occlusion Balloon Catheter
K182829 · DQY
MicroVention, Inc.
Neurology · 278d
Cleared Jul 10, 2019
DeepCT
K182875 · QAS
Deep01 Limited
Radiology · 271d
Cleared Jul 10, 2019
Full Digital Colour Doppler Ultrasonic Diagnostic System
K183041 · IYN
Wuhan Zoncare Bio-medical Electronics...
Radiology · 251d
Cleared Jul 10, 2019
Conometric Abutments
K183079 · NHA
Dentsply Sirona, Inc.
Dental · 247d
Cleared Jul 10, 2019
Velofix TLIF Cage
K183243 · MAX
U&I Corporation
Orthopedic · 231d
Cleared Jul 10, 2019
physIQ Heart Rhythm and Respiratory Module
K183322 · DPS
Physiq, Inc.
Cardiovascular · 222d
Cleared Jul 10, 2019
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K190011 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 188d
Cleared Jul 10, 2019
VeriSplint
K190107 · MQC
Whip Mix Corporation
Dental · 169d
Cleared Jul 10, 2019
Identify
K190137 · IYE
Varian Medical Systems, Inc.
Radiology · 162d