Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
73561–73584 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 10, 2003
DRI PRIMIDONE CALIBRATORS
K023780 · DLJ
Microgenics Corp.
Toxicology · 90d
Cleared Feb 10, 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Feb 10, 2003
VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER,...
K023800 · JOW
Aircast, Inc.
Cardiovascular · 88d
Cleared Feb 10, 2003
POLARIS DS
K024064 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 63d
Cleared Feb 10, 2003
ALLON 2001 VERSION 5
K024128 · DWJ
Mtre Advanced Technology , Ltd.
Cardiovascular · 56d
Cleared Feb 10, 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · LON
Becton, Dickinson & CO
Microbiology · 55d
Cleared Feb 10, 2003
THOR DDII 830CL3 LASER SYSTEM
K030226 · NHN
Thor Intl.
Physical Medicine · 19d