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
151609–151632 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 24, 1984
PRESSURE TRANSDUCER DOME 1295C
K841613 · DRS
Hewlett-Packard Co.
Cardiovascular · 184d
Cleared Oct 24, 1984
MINGOGRAF 7
K841868 · DSH
Siemens Medical Solutions USA, Inc.
Cardiovascular · 173d
Cleared Oct 24, 1984
JIMMY JOHN III
K842083 · KPL
Colon Therapeutics
Gastroenterology & Urology · 154d
Cleared Oct 24, 1984
MD308H DIGITAL/MB351H AUTO-BP MONITOR
K842200 · DXN
Sharp Electronics Corp.
Cardiovascular · 142d
Cleared Oct 24, 1984
HIP PROSTHESIS PACK
K842626
Deroyal Industries, Inc.
Orthopedic · 110d
Cleared Oct 24, 1984
DISPOSABLE PATIENT BLANKET
K843038 · KME
Anago, Inc.
General Hospital · 83d
Cleared Oct 24, 1984
ENTERAL FEEDING PUMP 14-800 SERIES
K843168 · FRN
Biosearch Medical Products, Inc.
General Hospital · 72d
Cleared Oct 24, 1984
MALLEABLE PENILE PROSTHESIS
K843280 · FAE
Mentor Corp.
Gastroenterology & Urology · 65d
Cleared Oct 24, 1984
MEDI-TECH DILATATION CATHETERS
K843383 · LIT
Medi-Tech, Inc.
Cardiovascular · 57d
Cleared Oct 24, 1984
HYDRO-SPLINT A SPONGE-COMPRESS DRESS
K843400 · FYH
Compression Splint Products, Inc.
General Hospital · 55d
Cleared Oct 24, 1984
KLEENIT BY QMED
K843559
Qmed, Inc.
General & Plastic Surgery · 44d
Cleared Oct 24, 1984
MSI SURGI-GRADE UNIVERSAL TRACH TRAY
K843561 · FSM
Medical Sterilization, Inc.
General & Plastic Surgery · 44d
Cleared Oct 24, 1984
MSI SURGI-GRADE DELUXE CUT-DOWN TRAY
K843562
Medical Sterilization, Inc.
General & Plastic Surgery · 44d
Cleared Oct 24, 1984
DERBYSHIRE DRAIN
K843575 · GBW
Sil-Med Corp.
General & Plastic Surgery · 43d
Cleared Oct 24, 1984
TICLIP STERIAL DISPOSABLE
K843589 · FZP
Western Medical Products, Inc.
General & Plastic Surgery · 42d
Cleared Oct 24, 1984
SURGIPRESS SURGICAL LOOP
K843593 · HRQ
Syntex Corp.
General & Plastic Surgery · 42d
Cleared Oct 24, 1984
SDC SILICONE SUMP DRAIN
K843617 · GBX
Science Development Corp.
General & Plastic Surgery · 40d
Cleared Oct 24, 1984
ST-200A W/MAXIMAL VOLUNTARY VENTILLAT-
K843700
Future Impex Corp.
Cardiovascular · 34d
Cleared Oct 24, 1984
COBE SATURATION CELL
K843709 · DRY
Cobe Laboratories, Inc.
Cardiovascular · 33d
Cleared Oct 24, 1984
API UNISCEPT MIC
K843732 · LTD
Analytical Products, Inc.
Microbiology · 30d
Cleared Oct 24, 1984
API UNISCEPT KB
K843733 · LTW
Analytical Products, Inc.
Microbiology · 30d
Cleared Oct 24, 1984
MODEL IM1074 END-TIDAL CO2 MODULE
K843970 · CCK
Gould, Inc.
Anesthesiology · 13d
Cleared Oct 24, 1984
PM-80 PULMOTESTER
K843984 · BZG
Future Impex Corp.
Anesthesiology · 13d
Cleared Oct 23, 1984
COLUMBIA CNA AGAR PLATE
K834419 · JSJ
Otisville Biotech, Inc.
Microbiology · 313d