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
154801–154824 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 10, 1984
IM-CHECK
K834345 · KTN
Diagnostic Technology, Inc.
Immunology · 60d
Cleared Feb 10, 1984
PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ
K834372 · GKL
Diagnostic Technology, Inc.
Hematology · 71d
Cleared Feb 10, 1984
URINARY DRAINAGE CONTAINER
K834448 · KNX
Vital Metrics, Inc.
Gastroenterology & Urology · 56d
Cleared Feb 10, 1984
ULTROSPEC W/APPLE II -4050-
K834489 · JJQ
Lkb Instruments, Inc.
Chemistry · 70d
Cleared Feb 10, 1984
MODEL M410D HEARING AID
K834523 · ESD
Radioear Corp.
Ear, Nose, Throat · 51d
Cleared Feb 10, 1984
ETHOX WEIGHTED FEEDING TUBE
K834554 · KNT
Ethox Corp.
Gastroenterology & Urology · 45d
Cleared Feb 10, 1984
COULTER COUNTER M2
K834568 · GKL
Coulter Electronics, Inc.
Hematology · 43d
Cleared Feb 10, 1984
REACH* TOOTHBRUSH
K834580 · EFW
Johnson & Johnson Professionals, Inc.
Dental · 43d
Cleared Feb 10, 1984
TOTAL IGE FAST TEST
K834594 · DGC
Allergenetics
Immunology · 43d
Cleared Feb 10, 1984
LIGHT TEST
K834598 · DHB
Hemogenetics, Inc.
Immunology · 42d
Cleared Feb 10, 1984
K-TUBE REPAIR KIT
K840019 · KNT
Midwest Metabolic Support Group
Gastroenterology & Urology · 36d
Cleared Feb 10, 1984
PREPAX DILUKIT PLUS
K840038 · GIF
Scientific Distributors, Inc.
Hematology · 36d
Cleared Feb 10, 1984
HEALTH-UP
K840040 · GZJ
Kung-Ho International, Inc.
Neurology · 35d
Cleared Feb 10, 1984
SDI PREPAX DILUKIT CA
K840042
Scientific Distributors, Inc.
Hematology · 35d
Cleared Feb 10, 1984
SDI PREPAX DILUKIT CT
K840043 · GIF
Scientific Distributors, Inc.
Hematology · 35d
Cleared Feb 10, 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · DHR
Diagnostic Products Corp.
Immunology · 35d
Cleared Feb 10, 1984
PEDIATRIC INTUBATION CIRCUIT
K840056 · CAI
Ackrad Laboratories
Anesthesiology · 35d
Cleared Feb 10, 1984
PRESERV GOMORI TRICHROME STAIN 125/500
K840087 · LED
Preventive Diagnostics Corp.
Microbiology · 31d
Cleared Feb 10, 1984
RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN
K840103 · JHR
Techniclone Intl.
Immunology · 31d
Cleared Feb 10, 1984
DOUBLE LUMEN INFUSION CATHETERS
K840175 · DQY
Medical Components, Inc.
Cardiovascular · 24d
Cleared Feb 10, 1984
NEUROMUSCLAR II
K840346 · IPF
Mentor Corp.
Physical Medicine · 15d
Cleared Feb 10, 1984
MARK III RESUSCITATOR
K840349 · BTM
Ambu, Inc.
Anesthesiology · 15d
Cleared Feb 10, 1984
DSP-200 DIGITAL STETHOSCOPE
K840604
William K. Hagan
General & Plastic Surgery
Cleared Feb 09, 1984
HDL EZ-TAB
K833160 · LBR
Preventive Diagnostics Corp.
Chemistry · 146d