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
168025–168048 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 1979
POPE UMBRELLA TUBE
K791680 · ETD
Xomed, Inc.
Ear, Nose, Throat · 78d
Cleared Nov 13, 1979
HTSH NEONATE RIA DIAGNOSTIC KIT
K791747 · JLW
Abbott Laboratories
Chemistry · 64d
Cleared Nov 13, 1979
CORNING GLYCOSYLATED HEMOGLOBIN SET
K791777 · LCP
Corning Medical & Scientific
Chemistry · 64d
Cleared Nov 13, 1979
BIOGUARD INFUSION LINE FILTER
K791822 · FPB
United States Surgical, A Division of...
General Hospital · 60d
Cleared Nov 13, 1979
LAP SPONGES
K791872 · EFQ
Carwild Corp.
General & Plastic Surgery · 53d
Cleared Nov 13, 1979
USCI SAFE-T-CLOTH THERMODILUTION CAT.
K791873 · KRB
C.R. Bard, Inc.
Cardiovascular · 53d
Cleared Nov 13, 1979
BACTO-HATTS
K791897 · GMT
Difco Laboratories, Inc.
Microbiology · 49d
Cleared Nov 13, 1979
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 49d
Cleared Nov 13, 1979
HEART RATE COMPUTER STRIP CHART
K791927 · JOM
Stanford Assoc., Inc.
Cardiovascular · 47d
Cleared Nov 13, 1979
ANTIBODY TO NATIVE DEOXYRIBONUCLEASE KIT
K791928 · DHN
Keith E. Abbott
Immunology · 47d
Cleared Nov 13, 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · JSS
Vitek Systems, Inc.
Microbiology · 47d
Cleared Nov 13, 1979
CONVERSION CONTRACTOR TIMER KIT
K791933 · IZO
Advanced Instrument Development, Inc.
Radiology · 47d
Cleared Nov 13, 1979
ATMOS ENT PATIENT CHAIR #1
K791937 · ETL
Jedmed Instrument Co.
Ear, Nose, Throat · 47d
Cleared Nov 13, 1979
ATMOS ENT PATIENT CHAIR #5
K791938 · ETL
Jedmed Instrument Co.
Ear, Nose, Throat · 47d
Cleared Nov 13, 1979
SHILEY CARDIOPLEGIC SOLUTION DEL SETS
K791947 · DWF
Shiley, Inc.
Cardiovascular · 43d
Cleared Nov 13, 1979
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
K791961 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 43d
Cleared Nov 13, 1979
USCI MULLINS TRANSSEPTAL CATHETER INTRO.
K791963 · DYB
C.R. Bard, Inc.
Cardiovascular · 43d
Cleared Nov 13, 1979
TECHNICON FAST-LC SYS. ANTICONVU DRUGS
K791979 · DPE
Technicon Instruments Corp.
Toxicology · 49d
Cleared Nov 13, 1979
STREP-SPEC
K791991 · JSS
Micro-Media Systems, Inc.
Microbiology · 41d
Cleared Nov 13, 1979
LANCER L-INA HUMAN REFERENCE SERUM
K792013 · JIX
Sherwood Medical Industries
Immunology · 39d
Cleared Nov 13, 1979
LANCER L-INA BUFFER, POLYMER, WASH SOLU
K792014 · JZW
Sherwood Medical Industries
Immunology · 39d
Cleared Nov 13, 1979
SILICONE RUBBER-BI NASOPHARYNGEAL AIR
K792018 · BTQ
Vesta, Inc.
Anesthesiology · 35d
Cleared Nov 13, 1979
WRIGHTS RAPID STAIN
K792026 · IAF
Mcb Manufacturing Chemists, Inc.
Hematology · 35d
Cleared Nov 13, 1979
NON-A-THERM
K792037 · KOD
Labarge, Inc.
Gastroenterology & Urology · 33d