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

Filters: Cleared only ×
176,076 results
154105–154128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 1984
ENTERNAL Y EXTENSION SET RECORDER
K840656 · KNT
Corpak Medsystems
Gastroenterology & Urology · 49d
Cleared Apr 04, 1984
PARAMAX ACID PHOSPHATASE REAGENT
K840661 · CKB
American Dade
Hematology · 49d
Cleared Apr 04, 1984
SENSIBEAD EIA IGE KIT
K840674 · DGC
Terumo Medical Corp.
Immunology · 49d
Cleared Apr 04, 1984
PDC HDL EZ-SEP CHOLESTEROL REAGENT
K840676 · LBS
Preventive Diagnostics Corp.
Chemistry · 49d
Cleared Apr 04, 1984
ASPARTATE AMINOTRANSFERASE REAGENT
K840706 · CIT
American Dade
Hematology · 47d
Cleared Apr 04, 1984
BAKTERIETTE-VI-PAK
K840719 · JTW
Great Lakes Intl.
Microbiology · 47d
Cleared Apr 04, 1984
IMMPULSE THEOPHYLLINE ASSAY REAGENTS
K840758 · LER
Paragon Diagnostics, Inc.
Toxicology · 41d
Cleared Apr 04, 1984
PARAMAX AMMONIA REAGENTT
K840770 · JIF
American Dade
Chemistry · 67d
Cleared Apr 04, 1984
CARBON DIOXIDE REAGENT
K840773 · KHS
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR I
K840774 · JIT
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CARBON DIOXIDE CALIBRATOR II
K840775 · JIT
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
PARAMAX CHOLESTEROL REAGENT
K840776 · CHH
American Dade
Chemistry · 56d
Cleared Apr 04, 1984
CREATINE KINASE MB REAGENT
K840783 · CGS
American Dade
Chemistry · 49d
Cleared Apr 04, 1984
S-CAL HEMATOLOGY CALIBRATOR
K840794 · KRY
Coulter Electronics, Inc.
Hematology · 41d
Cleared Apr 04, 1984
SWABZYME-OXIDASE
K840810 · JTO
E-Y Laboratories, Inc.
Microbiology · 61d
Cleared Apr 04, 1984
ENDOTOME PNEUMATIC ORTHOPAEDIC CUT
K840831 · HSZ
Cabot Medical Corp.
Orthopedic · 40d
Cleared Apr 04, 1984
IMMPULSE TOBRAMYCIN ASSAY REAGENTS
K840847 · LCR
Paragon Diagnostics, Inc.
Toxicology · 40d
Cleared Apr 04, 1984
SERATEST RF LATEX DETERMINATION
K840863 · DHR
Seragen Diagnostics, Inc.
Immunology · 40d
Cleared Apr 04, 1984
DIETO CONTAINER FOR ENTERNAL NUTRIT
K840916 · KNT
Gil-Med Industries C/O Kegan & Kegan,...
Gastroenterology & Urology · 35d
Cleared Apr 04, 1984
PHILLY INFANT BOLT
K840999 · GWM
Philadelphia Medical Specialties
Neurology · 26d
Cleared Apr 04, 1984
MANUAL BLOOD CELL COUNTING DEVICE
K841026 · GKM
Instrumentation Laboratory CO
Hematology · 23d
Cleared Apr 04, 1984
BANGORT LIFESTYLE COLOSTOMY POUCHES
K841029 · EXB
Howmedica Corp.
Gastroenterology & Urology · 23d
Cleared Apr 04, 1984
TTI REHABILATATION GYM SYS
K841112 · IPF
Therapeutic Technologies, Inc.
Physical Medicine · 20d
Cleared Apr 04, 1984
GASPAK PLUS DISPOS. HYDROGEN &
K841117 · KZJ
Bd Becton Dickinson Vacutainer...
Microbiology · 20d