FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
22009–22032 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jul 10, 2019
MariGen Wound Extra
K190528 · KGN
Kerecis Limited
General & Plastic Surgery · 128d
Cleared Jul 10, 2019
SpeediCath Flex Coude Pro
K190620 · GBM
Coloplast
Gastroenterology & Urology · 121d
Cleared Jul 10, 2019
PressOn Electrode Headset
K190801 · GXZ
Rhythmlink International, LLC
Neurology · 103d
Cleared Jul 10, 2019
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K190818 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 100d
Cleared Jul 10, 2019
Salvo™ Spine System
K191045 · NKB
Spine Wave, Inc.
Orthopedic · 82d
Cleared Jul 10, 2019
Nexxt Matrixx System
K191408 · MAX
Nexxt Spine, LLC
Orthopedic · 43d
Cleared Jul 10, 2019
Vave Personal Ultrasound System
K191541 · IYO
Vave Health, Inc.
Radiology · 29d
Cleared Jul 10, 2019
CentriMag Acute Circulatory Support System
K191557 · DWA
Thoratec Corporation (Now Part of...
Cardiovascular · 28d
Cleared Jul 10, 2019
Calprest, EasyCal
K191589 · NXO
Eurospital S.P.A.
Immunology · 26d
Cleared Jul 10, 2019
CalprestNG, EasyCal
K191592 · NXO
Eurospital S.P.A.
Immunology · 26d
Cleared Jul 09, 2019
SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F,...
K180994 · KMK
Interrad Medical, Inc.
General & Plastic Surgery · 449d
Cleared Jul 09, 2019
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch...
K181957 · FRG
Tianchang Jiarui Packaging Material...
General Hospital · 351d
Cleared Jul 09, 2019
Shear Stress Therapeutics SST 3000
K182163 · IPF
Shear Stress Therapeutics, LLC
Physical Medicine · 333d
Cleared Jul 09, 2019
LifeSPARC Pump, LifeSPARC Controller
K183623 · KFM
Cardiacassist, Inc.
Cardiovascular · 195d