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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
145585–145608 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1986
SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM
K855116 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 63d
Cleared Feb 24, 1986
SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM
K855117 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 63d
Cleared Feb 24, 1986
S.L.T. CONTACT LASER
K855119 · LNK
Surgical Laser Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 24, 1986
ANGIOMED RENAL DILATION SET
K855140 · KOD
Angiomed U.S., Inc.
Gastroenterology & Urology · 60d
Cleared Feb 24, 1986
MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
K860202 · DXY
Cook Pacemaker Corp.
Cardiovascular · 33d
Cleared Feb 24, 1986
BIOTIS CLOSTRIDIUM DIFFICILE AGAR
K860383 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MODIFIED THAYER MARTIN
K860384 · JTY
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MAC-MUG
K860385 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SF BROTH
K860386 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS KF STREPTOCOCCUS AGAR
K860388 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN
K860390 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT
K860391 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS CETRIMIDE AGAR
K860394 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS HAEMPHILLUS ISOLATION AGAR
K860395 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS NUTRIENT GELATIN
K860396 · JTO
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSA
K860397 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS POTATO DEXTROSE AGAR
K860398 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TODD HEWITT BROTH
K860399 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TRYPTIC SOY AGAR SLANTS
K860401 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS BISMUTH SULFITE AGAR
K860402 · JSI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSA WITH 5% RABBIT BLOOD
K860403 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H10 AGAR SLANT
K860404 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSB WITH 6.5% NACL
K860405 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS MIDDLEBROOK 7H9 BROTH
K860406 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d