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
145609–145632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1986
BIOTIS ANAEROBIC CNA
K860407 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS NUTRIENT AGAR
K860408 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS COLUMBIA SHEEP BLOOD AGAR
K860409 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS COOKED MEAT
K860410 · KZI
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS BHI AGAR
K860411 · JSG
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SIM MEDIUM
K860412 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS TSI
K860413 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS ORNITHINE INDOLE MOTILITY MEDIA
K860414 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS SIMMON CITRATE AGAR
K860415 · JSE
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
BIOTIS REGAN-LOWE
K860416 · JSJ
Otisville Biotech, Inc.
Microbiology · 21d
Cleared Feb 24, 1986
SICKLE CELL REAGENT SET
K860420 · GHM
Sterling Diagnostics, Inc.
Hematology · 20d
Cleared Feb 24, 1986
MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
K860466 · DXY
Cook Pacemaker Corp.
Cardiovascular · 18d
Cleared Feb 24, 1986
EUROTAN BY AYK
K860489 · FTC
Eurotan Intl.
General & Plastic Surgery · 14d
Cleared Feb 21, 1986
COMBISCOPE
K852655 · KNG
Instrument Technology, Inc.
Obstetrics & Gynecology · 242d
Cleared Feb 21, 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240 · JOP
Johnson & Johnson Professionals, Inc.
Cardiovascular · 204d
Cleared Feb 21, 1986
ALVEO-DIFFUSION TEST
K853443 · BZC
Erich Jaeger, Inc.
Anesthesiology · 189d
Cleared Feb 21, 1986
ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
K853876 · HHR
Endo Lase, Inc.
Obstetrics & Gynecology · 157d
Cleared Feb 21, 1986
ENDO-LASE CD40 CO2 FOR GYNECOLOGY
K853903 · HHR
Endo Lase, Inc.
Obstetrics & Gynecology · 154d
Cleared Feb 21, 1986
HOFMANN KNEE
K853991 · JWH
Intermedics Orthopedics
Orthopedic · 147d
Cleared Feb 21, 1986
VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &
K853992 · GZJ
Valley Forge Scientific Corp.
Neurology · 147d
Cleared Feb 21, 1986
TDX TRANSFERRIN DIAGNOSTIC KIT
K854416 · DDG
Abbott Laboratories
Immunology · 109d
Cleared Feb 21, 1986
MEVAMATIC 3
K854609 · JAD
Siemens Medical Laboratories, Inc.
Radiology · 95d
Cleared Feb 21, 1986
CERAPEARL
K854763 · EIH
Kyocera International, Inc.
Dental · 86d
Cleared Feb 21, 1986
FLEX-I-GRASP
K854889 · HRX
Euro-Med Intl.
Orthopedic · 77d