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
28417–28440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
K171062 · DXN
Andon Health Co, Ltd.
Cardiovascular · 113d
Cleared Aug 01, 2017
Calix-C Cervical Interbody Spacer
K171075 · ODP
X-Spine Systems, Inc.
Orthopedic · 112d
Cleared Aug 01, 2017
HEXA100 (hexafocon A) Daily Wear Contact Lenses
K171077 · HQD
Contamac, Ltd.
Ophthalmic · 112d
Cleared Aug 01, 2017
Q-Switched Nd:YAG Laser System
K171079 · GEX
Ids, Ltd.
General & Plastic Surgery · 112d
Cleared Aug 01, 2017
Advanced RBC Application
K171315 · JOY
CellaVision AB
Hematology · 89d
Cleared Aug 01, 2017
M.U.S.T. MINI Posterior Cervical Screws System
K171369 · NKG
Medacta International S.A.
Orthopedic · 83d
Cleared Aug 01, 2017
14Fr Colon Decompression Set, Macon Colon Decompression Set
K171619 · FEG
Cook Ireland, Ltd.
Gastroenterology & Urology · 60d
Cleared Aug 01, 2017
Trojan Supra Lubricated Polyurethane Male Condom
K171639 · MOL
Church & Dwight Co., Inc.
Obstetrics & Gynecology · 60d
Cleared Aug 01, 2017
M.U.S.T. Combined Set Screws
K171758 · NKB
Medacta International S.A.
Orthopedic · 48d
Cleared Aug 01, 2017
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with...
K171870 · JWY
Thermo Fisher Scientific
Microbiology · 40d
Cleared Aug 01, 2017
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL
K171906 · JWY
Liofilchem S. R. L.
Microbiology · 36d
Cleared Aug 01, 2017
HardyDisk AST Delafloxacin 5 µg (DLX5)
K171975 · JTN
Hardy Diagnostics
Microbiology · 32d
Cleared Jul 31, 2017
Electronic Blood Pressure Monitor
K161845 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 391d
Cleared Jul 31, 2017
bellavista 1000
K163127 · CBK
Imtmedical AG
Anesthesiology · 265d
Cleared Jul 31, 2017
Youha electric breast pump
K163136 · HGX
Ningbo Youhe Electrical Appliance...
Obstetrics & Gynecology · 265d
Cleared Jul 31, 2017
Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with...
K163598 · KCT
Advanced Sterilization Products
General Hospital · 222d
Cleared Jul 31, 2017
Obturys
K170207 · KIF
Itena Clinical
Dental · 188d
Cleared Jul 31, 2017
WEGO-PTFE
K170842 · NBY
Foosin Medical Supplies Inc., Ltd.
General & Plastic Surgery · 132d
Cleared Jul 31, 2017
Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD...
K171040 · ITX
Koelis
Radiology · 116d
Cleared Jul 31, 2017
Carefusion NeutraClear Needle-free connector
K171132 · FPA
Cair Lgl
General Hospital · 105d
Cleared Jul 31, 2017
Scanmate Flex
K171301 · IYO
Dgh Technology, Inc.
Radiology · 89d
Cleared Jul 31, 2017
NuBODY Skin Toning Device
K171588 · NFO
Carol Cole Company Dba Nuface
Neurology · 61d
Cleared Jul 31, 2017
Bronchi and Gastrointestinal Cytology Brush
K171607 · FDX
Wilson-Cook Medical Inc./Cook Endoscopy
Gastroenterology & Urology · 60d
Cleared Jul 31, 2017
Xingyu Nitrile Powder Free Patient Examination Gloves, White color
K171615 · LZA
Shandong Xingyu Gloves Co., Ltd.
General Hospital · 60d