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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
150769–150792 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 23, 1984
MANNITOL-SALT AGAR USP PLATE
K834420 · JSI
Otisville Biotech, Inc.
Microbiology · 313d
Cleared Oct 23, 1984
PHENYLETHYL ALCOHOL AGAR PLATE
K834422 · JSJ
Otisville Biotech, Inc.
Microbiology · 313d
Cleared Oct 23, 1984
S S AGAR PLATE
K834423 · JSI
Otisville Biotech, Inc.
Microbiology · 313d
Cleared Oct 23, 1984
SFP AGAR PLATES
K834424 · JSJ
Otisville Biotech, Inc.
Microbiology · 313d
Cleared Oct 23, 1984
ALL PURPOSE ELECTROSURGICAL GENERATOR
K841483 · GEI
Concept, Inc.
General & Plastic Surgery · 196d
Cleared Oct 23, 1984
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY
K841961 · LIT
Scimed Life Systems, Inc.
Cardiovascular · 162d