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
157105–157128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1983
REFEREE BRAND CO-OXIMETER REAGENTS
K830180 · KHG
Analytical Products, Inc.
Hematology · 80d
Cleared Apr 08, 1983
ARTIMICROBIAL REMOVAL DEVICE
K830372 · LJF
Marion Laboratories, Inc.
Microbiology · 63d
Cleared Apr 08, 1983
CYNOX I HEMOGLOBINOMETER
K830569 · JJQ
Buffalo Medical Specialties Mfg., Inc.
Hematology · 45d
Cleared Apr 08, 1983
BREATHING FILTER
K830618 · CAH
Ohio Medical Products
General Hospital · 39d
Cleared Apr 08, 1983
POLYSTYRENE MICROTITER PLATE IMMUNOSORB
K830653 · DGO
Diagnostic Reagent Tech.
Immunology · 38d
Cleared Apr 08, 1983
FIAX COMPLEMENT C4 TEST KIT
K830669 · DBI
Intl. Diagnostic Technology
Immunology · 35d
Cleared Apr 08, 1983
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
K830680 · BSZ
Narco Scientific
Anesthesiology · 35d
Cleared Apr 08, 1983
DUPONT PREP TYPE CS EXTRACTION CARTRIDE
K830694
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 32d
Cleared Apr 08, 1983
QUANTUM II BACTERIAL IDENT. SYSTEM
K830698 · JSS
Abbott Laboratories
Microbiology · 32d
Cleared Apr 08, 1983
MINI LANCET-BLOOD LANCET
K830705 · FMA
Pharmaquest Corp.
General Hospital · 32d
Cleared Apr 08, 1983
NETILMICIN 30 MCG ANTIMICROBIAL DISK
K830731 · JTN
General Diagnostics
Microbiology · 31d
Cleared Apr 08, 1983
NETILMICIN 30 MCG SENSI DISC
K830732 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 31d
Cleared Apr 08, 1983
KOALA C99 I.V. CONTROLLER
K830780 · LDR
Chesebrough-Pond'S U.S.A. Co.
General Hospital · 28d
Cleared Apr 08, 1983
VERI-STAPH
K830783 · JWX
Zeus Technologies
Microbiology · 28d
Cleared Apr 08, 1983
LEECO DIG-QUANT DIAG. TEST KIT
K830785
Leeco Diagnostics, Inc.
Chemistry · 28d
Cleared Apr 08, 1983
KNAI SODIUM POTASSIUM ANALYZER
K830805 · JSG
Radiometer America, Inc.
Chemistry · 25d
Cleared Apr 08, 1983
LEECO T3-RIA DIAGNOSTIC KIT
K830808 · CDP
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared Apr 08, 1983
S & W MODEL SW 37
K830874 · INQ
S & W Enterprises, Inc.
Physical Medicine · 21d
Cleared Apr 08, 1983
S & W MODEL 29
K830875 · JFB
S & W Enterprises, Inc.
Physical Medicine · 21d
Cleared Apr 08, 1983
H-H IN-LINE VALVED CATHETER 2 TYPES
K830894 · JXG
Holter-Hausner Intl.
Neurology · 18d
Cleared Apr 08, 1983
PLAYTEX TAMPONS
K830966 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 11d
Cleared Apr 06, 1983
ASPITRON
K823088 · HQC
Intl. Ophthalmic Industries Corp.
Ophthalmic · 169d
Cleared Apr 06, 1983
GLUCOSE REAGENT
K823537 · FMF
Ac Biochemical Laboratories, Inc.
Chemistry · 127d
Cleared Apr 06, 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585 · DSI
Brentwood Instruments, Inc.
Cardiovascular · 121d