FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
72433–72456 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 11, 2003
STERILE POWDERED LATEX PATIENT EXAMINATION GLOVES
K023915 · LYY
Sanrea Healthcare Private Limited
General Hospital · 78d
Cleared Feb 11, 2003
MARK I THERMAL IMAGER
K023925 · LHQ
Ix-Dr, Inc.
Radiology · 78d
Cleared Feb 11, 2003
BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST
K023944 · JHI
Bayer Corp.
Chemistry · 77d
Cleared Feb 11, 2003
WAKO NEFA LINEARITY SET
K030065 · JJX
Wako Chemicals USA, Inc.
Toxicology · 35d
Cleared Feb 11, 2003
GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM
K030199 · KPS
General Electric Co.
Radiology · 21d
Cleared Feb 11, 2003
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K030313 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 12d
Cleared Feb 10, 2003
GOLDWAY DIGITAL VIDEO COLPOSCOPE IMAGING SYSTEM, MODEL #SLC-2000
K021153 · HEX
Goldway Us, Inc.
Obstetrics & Gynecology · 306d
Cleared Feb 10, 2003
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K022856 · GEI
Aaron Medical Industries
General & Plastic Surgery · 167d
Cleared Feb 10, 2003
ACON STREP A TWIST TEST DEVICE
K023766 · GTY
Acon Laboratories Co.
Microbiology · 90d