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
162505–162528 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 08, 1981
GINGI-PLAIN CORDS & BRAIDS
K812120 · JES
Belport Co., Inc.
Dental · 43d
Cleared Sep 08, 1981
VISIO-FIL
K812169 · EBF
Espe GmbH (Us)
Chemistry · 40d
Cleared Sep 08, 1981
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K812272 · FRC
Sybron Corp.
General Hospital · 26d
Cleared Sep 08, 1981
PRISMA-FIL COMPULES
K812277 · EID
Caulk Co., Div. Dentsply
Dental · 26d
Cleared Sep 08, 1981
ZEE ELECTRODE-GEL
K812284 · GYB
Zee Medical Products Co., Inc.
Neurology · 26d
Cleared Sep 08, 1981
SHILEY FENESTRATED LOW PRESS. CUFFED
K812302 · JOH
Shiley, Inc.
Anesthesiology · 25d
Cleared Sep 08, 1981
MONTG. ESOPHAGEAL -SALIVARY BYPASS- TUBE
K812305 · KCF
Boston Medical Products, Inc.
Ear, Nose, Throat · 22d
Cleared Sep 08, 1981
SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT
K812328 · DEW
Scripps-Miles, Inc.
Immunology · 21d
Cleared Sep 08, 1981
CYCLES REUSABLE MENSTRUAL PADS
K812333 · HHD
Cycles
Obstetrics & Gynecology · 21d
Cleared Sep 08, 1981
GUINEA PIG COMPLEMENT VIRUS ANTIBODY
K812369 · KTQ
Dutchland Laboratories, Inc.
Immunology · 19d
Cleared Sep 08, 1981
GUINEA PIG COMPLEMENT REGULAR
K812370 · KTQ
Dutchland Laboratories, Inc.
Immunology · 19d
Cleared Sep 08, 1981
HEMOLYSIN
K812371
Dutchland Laboratories, Inc.
Immunology · 19d
Cleared Sep 08, 1981
GUINEA PIG SERUM - STERILE
K812379 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
RABBIT SERUM - STERILE
K812380 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR HORSE SERUM - STERILE
K812381 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
DONOR CALF (BOVINE-SERUM) - STERILE
K812382 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
CALF (BOVINE) SERUM - STERILE
K812383 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NEWBORN CALF SERUM - STERILE
K812384 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
NATAL CALF (BOVINE) SERUM - STERILE
K812385 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
FETAL BOVINE SERUM - STERILE
K812386 · KIS
Dutchland Laboratories, Inc.
Pathology · 19d
Cleared Sep 08, 1981
MRI GENTAMICIN RIA KIT
K812394 · DJB
Microanalytic Research, Inc.
Microbiology · 19d
Cleared Sep 01, 1981
REAGENT STRIPS FOR URINALYSIS
K811342 · JRE
Miles Laboratories, Inc.
Chemistry · 112d
Cleared Sep 01, 1981
TANDEM PAP KIT - (PARTS I & II)
K811959 · JFH
Hybritech, Inc.
Chemistry · 54d
Cleared Sep 01, 1981
HERPES VIRUS HOMINIS ANTIBODY TEST SYS.
K812085 · GQL
Zeus Scientific, Inc.
Microbiology · 41d