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

Filters: Cleared only ×
175,820 results
29641–29664 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 16, 2017
LOCI Total Vitamin D Total Assay, LOCI VITD CAL
K162298 · MRG
Siemens Healthcare Diagnostics
Chemistry · 212d
Cleared Mar 16, 2017
NuVasive Next Generation NVM5 System
K162313 · PDQ
Nu Vasive, Incorporated
Neurology · 210d
Cleared Mar 16, 2017
TIPCAM 1S 3D System
K162880 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 153d
Cleared Mar 16, 2017
Y3 Proximal Femoral Plate System
K163003 · HRS
Pega Medical, Inc.
Orthopedic · 139d
Cleared Mar 16, 2017
6200 Ultrasound System and 6250 Ultrasound System
K163082 · IYN
Esaote, S.P.A.
Radiology · 133d
Cleared Mar 16, 2017
KYMCO EQ10D Scooter
K163201 · INI
Kwang Yang Motor Co., Ltd.
Physical Medicine · 121d
Cleared Mar 16, 2017
NuVasive Modulus XLIF Interbody System
K163230 · MAX
Nu Vasive, Incorporated
Orthopedic · 119d
Cleared Mar 16, 2017
Kalitec Direct InSePtion™ MIS Fixation System
K163471 · PEK
Kalitec Direct, LLC
Orthopedic · 94d
Cleared Mar 16, 2017
VALIDATE Heparin Calibration Verification/Linearity Test Kit
K163498 · GGN
Maine Standards Company, LLC
Hematology · 93d
Cleared Mar 16, 2017
FDX Console (DR-ID300CL) Software
K170451 · LLZ
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 29d
Cleared Mar 16, 2017
MectaLIF Anterior Stand Alone
K170455 · OVD
Medacta International S.A.
Orthopedic · 29d
Cleared Mar 15, 2017
Spectra 9Plus
K162415 · HGX
Uzinmedicare Company
Obstetrics & Gynecology · 198d
Cleared Mar 15, 2017
SleepWeaver 3D Nasal Mask
K162905 · BZD
Circadiance, LLC
Anesthesiology · 149d
Cleared Mar 15, 2017
MOJAVE Expandable Interbody System
K163364 · MAX
K2m
Orthopedic · 105d
Cleared Mar 15, 2017
LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source
K163572 · KXK
Lv Liberty Vision Corp.
Radiology · 86d
Cleared Mar 14, 2017
Rapid Barostat Bag (RBB) Pump and Catheter
K160287 · FFX
Mui Scientific
Gastroenterology & Urology · 405d
Cleared Mar 14, 2017
NobelZygoma 0°
K161598 · DZE
Nobel Biocare AB
Dental · 278d
Cleared Mar 14, 2017
THD ANOPRESS
K161785 · KLA
Thd Spa
Gastroenterology & Urology · 258d
Cleared Mar 14, 2017
NIVR58-T kit
K161880 · DXJ
Barco N.V.
Cardiovascular · 249d
Cleared Mar 14, 2017
TotalC-Ram
K162960 · EMA
Itena Clinical
Dental · 141d
Cleared Mar 14, 2017
Safety Blood Collection Set
K163093 · FMI
Jiangsu Shenli Medical Production...
General Hospital · 130d
Cleared Mar 14, 2017
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL
K163517 · JWY
Liofilchem S. R. L.
Microbiology · 89d
Cleared Mar 14, 2017
FilmArray Warrior Control Panel M290
K163522 · PMN
Maine Molecular Quality Controls, Inc.
Microbiology · 89d
Cleared Mar 14, 2017
HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40
K170127 · JTN
Hardy Diagnostics
Microbiology · 60d