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

Filters: Cleared only ×
176,076 results
61393–61416 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 18, 2006
ADMIRAL XTREME PTA CATHETER
K062809 · DQY
Invatec Innovative Technologies
Cardiovascular · 29d
Cleared Oct 18, 2006
MASTALEX -MRSA, MODEL RST501
K062864 · MYI
Mast Group , Ltd.
Microbiology · 23d
Cleared Oct 18, 2006
ENSEAL PTC TISSUE SEATING SEALING DEVICE
K062949 · GEI
Surgrx, Inc.
General & Plastic Surgery · 19d
Cleared Oct 18, 2006
CENTARISONE RIS/PACS
K063037 · LLZ
Centarisone, LLC
Radiology · 15d
Cleared Oct 18, 2006
ENSEAL PTC TISSUE SEALING DEVICE
K063097 · GEI
Surgrx, Inc.
General & Plastic Surgery · 8d
Cleared Oct 18, 2006
SYNGO LUNG CAD
K063877 · OEB
Siemens Medical Solutions USA, Inc.
Radiology · 6d
Cleared Oct 17, 2006
PAJUNK MULTISTIM SENSOR NERVE STIMULATORS
K061172 · BXN
PAJUNK GmbH Medizintechnologie
Anesthesiology · 173d
Cleared Oct 17, 2006
SOLITAIRE ANTERIOR SPINAL SYSTEM
K062810 · MQP
Ebi, L.P.
Orthopedic · 28d
Cleared Oct 17, 2006
FOX SV PTA CATHETER
K062843 · LIT
Abbott Laboratories
Cardiovascular · 25d
Cleared Oct 17, 2006
POWERTOME PERIOTOME
K063007 · EKX
Westport Medical, Inc.
Dental · 15d
Cleared Oct 16, 2006
ABL8X7 FLEX
K051968 · CGL
Radiometer Medical Aps
Chemistry · 453d
Cleared Oct 16, 2006
POLARCOAT
K052907 · GEI
Patton Surgical Corp.
General & Plastic Surgery · 367d
Cleared Oct 16, 2006
CONMED LINVATEC INSTRUMENT STERILIZATION TRAY
K052992 · FRG
Conmed Linvatec
General Hospital · 356d
Cleared Oct 16, 2006
MANUEL SAFTEY SYRINGE PARTS 1 & 2
K060772 · MEG
Medsafe Asa
General Hospital · 208d
Cleared Oct 16, 2006
PMP4 APPLICATION
K061428 · MSX
Card Guard Scientific Survival , Ltd.
Cardiovascular · 146d
Cleared Oct 16, 2006
CODMAN VPV SYSTEM, MODEL 82-3192
K061876 · JXG
Codman & Shurtleff, Inc.
Neurology · 105d
Cleared Oct 16, 2006
CONFIDANT 2.0
K062215 · DRG
Confidant, Inc.
Cardiovascular · 76d
Cleared Oct 16, 2006
CAREVENT
K062240 · KNY
Chief Medical, LLC
Gastroenterology & Urology · 75d
Cleared Oct 16, 2006
AXIOM PULSED LIGHT SYSTEM
K062312 · GEX
General Project S.R.L.
General & Plastic Surgery · 69d
Cleared Oct 16, 2006
NOVASPINE POWERED SUCTION PUMP PRO-1
K062456 · OMP
Novaspine, LLC
General & Plastic Surgery · 54d
Cleared Oct 16, 2006
SERENO ELECTRONIC STETHOSCOPE
K062481 · DQD
Pishon High Tech Co., Ltd.
Cardiovascular · 53d
Cleared Oct 16, 2006
AUDIT MICROCV IMMUNOASSAY LINEARITY SET
K062668 · JJY
Aalto Scientific, Ltd.
Chemistry · 38d
Cleared Oct 16, 2006
DMS 300-2, 300-3 AND 300-4
K062959 · MWJ
Diagnostic Monitoring Software
Cardiovascular · 17d
Cleared Oct 16, 2006
COMFORT SCOOTER, MODEL LY-EW415
K063032 · INI
Comfort Orthopedic Co., Ltd.
Physical Medicine · 13d