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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72937–72960 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 1000
K023801 · IXW
S.A.I.E.P. S.R.L.
Radiology · 90d
Cleared Feb 12, 2003
FILM PROCESSOR, MODEL LIFE RAY PRO 2500
K023825 · IXW
S.A.I.E.P. S.R.L.
Radiology · 90d
Cleared Feb 12, 2003
WIENER LAB COLINESTERASA AA
K023992 · DIH
Wiener Laboratories Saic
Chemistry · 72d
Cleared Feb 12, 2003
WELCH ALLYN VITAL SIGN MONITOR WITH MP506
K024005 · DXN
Welch Allyn, Inc.
Cardiovascular · 70d
Cleared Feb 12, 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
K024082 · GJT
Instrumentation Laboratory CO
Hematology · 63d
Cleared Feb 12, 2003
WIENER LAB. BILIRUBINA DIRECT AA
K024116 · CIG
Wiener Laboratories Saic
Chemistry · 61d
Cleared Feb 12, 2003
PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
K024147 · MQB
Varian Medical Systems, Inc.
Radiology · 58d
Cleared Feb 12, 2003
COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A)...
K024164 · HQD
Metro Optics, Inc.
Ophthalmic · 57d
Cleared Feb 12, 2003
STEALTHSTATION SYSTEM ADVANCED CONTOUR REGISTRATION SOFTWARE MODULE
K030106 · HAW
Medtronic Surgical Navigation...
Neurology · 30d
Cleared Feb 12, 2003
ENHANCE-S PLUS H
K030116 · MQL
Conception Technology, Inc.
Obstetrics & Gynecology · 30d
Cleared Feb 12, 2003
ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002
K030338 · GEX
Curelight, Ltd.
General & Plastic Surgery · 12d
Cleared Feb 11, 2003
MEDSTAR SYSTEM, MODELS 533-300
K020534 · DXH
Cybernet Medical
Cardiovascular · 357d
Cleared Feb 11, 2003
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCESSORIES
K021852 · GEI
Olympus Optical Co., Ltd.
General & Plastic Surgery · 251d
Cleared Feb 11, 2003
TWLIGHT, MODEL ISP 9600
K022642 · BZD
Invacare Corp.
Anesthesiology · 187d
Cleared Feb 11, 2003
HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM
K022747 · FIP
Hydropure Systems, Inc.
Gastroenterology & Urology · 176d
Cleared Feb 11, 2003
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
K023248 · FGE
Orbus Medical Technologies
Gastroenterology & Urology · 134d
Cleared Feb 11, 2003
TECHNOS MP, MODEL AU6
K023255 · IYN
Biosound Esaote, Inc.
Radiology · 134d
Cleared Feb 11, 2003
EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE
K023401 · ODG
Pentax Precision Instrument Corp.
Radiology · 125d
Cleared Feb 11, 2003
TRILAMINATE DRAPES/TIBURON
K023419 · KKX
Allegiance Healthcare Corp.
General Hospital · 123d
Cleared Feb 11, 2003
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K023793 · BTM
Portex, Inc.
Anesthesiology · 90d
Cleared Feb 11, 2003
LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050
K023805 · CBP
Laerdal Medical A/S
Anesthesiology · 89d
Cleared Feb 11, 2003
CLEARFIL SE BOND PLUS
K023842 · KLE
Kuraray Medical, Inc.
Dental · 85d
Cleared Feb 11, 2003
STERILE PATIENT POWDERFREE LATEX EXAMINATION GLOVES
K023910 · LYY
Sanrea Healthcare Private Limited
General Hospital · 78d
Cleared Feb 11, 2003
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER...
K023912 · KGO
Sanrea Healthcare Private Limited
General Hospital · 78d