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
153961–153984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 09, 1984
PREPACELL-STERILE-BONE MARROW ASPIR
K833438 · KDD
Applied Medical Devices, Inc.
General & Plastic Surgery · 127d
Cleared Feb 09, 1984
SUNBED/SUNROOF TANNING DEVICE
K833524 · FTC
J B Trading BV
General & Plastic Surgery · 142d
Cleared Feb 09, 1984
CAPD PREP KIT
K833780 · FKG
Professional Dialysis Products
Gastroenterology & Urology · 104d
Cleared Feb 09, 1984
CREIGHTON FIXATOR
K833907 · JDW
Patton Machine Co.
Orthopedic · 87d
Cleared Feb 09, 1984
GENUCOM
K834462 · LYH
Far Orthopedics, Inc.
Neurology · 52d
Cleared Feb 09, 1984
MERRITTAN SUN SYSTEM
K834488 · FTC
Interfit A.G. Dba/Int'L Tanning Sys
Radiology · 57d