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

Filters: Cleared only ×
175,820 results
143881–143904 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · KTN
Armkel, LLC
Immunology · 37d
Cleared Jul 03, 1986
MULTI-DAY ELECTRODES
K862011 · GXY
Medical Electronic Assn.
Neurology · 36d
Cleared Jul 03, 1986
CONCORD CARE TRAY
K862039
Concord Laboratories, Inc.
General & Plastic Surgery · 36d
Cleared Jul 03, 1986
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD
K862052 · DTB
Intermedics, Inc.
Cardiovascular · 35d
Cleared Jul 03, 1986
PERENNIAL RYE ALLERGEN DISC
K862173 · DHB
Immuno Nuclear Corp.
Immunology · 24d
Cleared Jul 03, 1986
ENGLISH PLAINTAIN ALLERGEN DISC
K862264 · DHB
Immuno Nuclear Corp.
Immunology · 20d
Cleared Jul 03, 1986
AMPLIFIED ELISA IGE KIT
K862368 · DGC
Allertec, Inc.
Immunology · 9d
Cleared Jul 03, 1986
BIOTIS HAEMOPHILUS IDENTIFICATION QUAD
K862387 · JSH
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS TCBS AGAR
K862388 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS ACETAMIDE AGAR
K862389 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS BORDET GENGOU AGAR
K862390 · KZI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DESOXYCHOLATE AGAR
K862391 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS MOTILITY TEST MEDIUM
K862392 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS LITMUS MILK
K862393 · JSE
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS MITIS SALIVARIUS
K862394 · JSI
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, BASE
K862395 · JSH
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, ARGININE
K862396 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, LYSINE
K862397 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
K862398 · JSF
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS SXT AGAR
K862399 · JSJ
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
BIOTIS KV LAKED BLOOD AGAR
K862400 · JSJ
Otisville Biotech, Inc.
Microbiology · 9d
Cleared Jul 03, 1986
NICKEL,20% CHROMIUM PORCELAIN FUSED TO METAL ALLOY
K862417 · EJH
Austenal Dental, Inc.
Dental · 8d
Cleared Jul 02, 1986
ANTI-LEU-12 B CELL REAGENT
K851639 · LJD
Bd Becton Dickinson Vacutainer...
Hematology · 439d
Cleared Jul 02, 1986
GLUCOMETER M BLOOD GULCOSE METER
K855202 · CGA
Miles Laboratories, Inc.
Chemistry · 188d