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
151273–151296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1984
FORMACLEAR- & MULTIPLE
K842131 · FKQ
Rna Medical Corp.
Pathology · 103d
Cleared Sep 10, 1984
AIMED FOLEY CATHETER VARIOUS SIZES
K842228 · KOD
Tech-Cons Ltd., Intl.
Gastroenterology & Urology · 97d
Cleared Sep 10, 1984
ELVI 146 SEROSCAN
K842313 · JQT
Logos Scientific, Inc.
Chemistry · 90d
Cleared Sep 10, 1984
URETHRAL CATHETERIZATION TRAY
K842866 · KOD
Inmed Corp.
Gastroenterology & Urology · 49d
Cleared Sep 10, 1984
CURITY SUPRAPUBIC DRAINAGE SYSTEM
K842899 · LJE
The Kendal Co.
Gastroenterology & Urology · 49d
Cleared Sep 09, 1984
SICKLING HEMOGLOBIN CONTROLS, NORMAL
K842152 · GHM
Isolab, Inc.
Hematology · 102d
Cleared Sep 07, 1984
CMV LATEX AGGLUTINATION TEST KIT
K841520 · LJO
Bd Becton Dickinson Vacutainer...
Microbiology · 148d
Cleared Sep 07, 1984
RADIOEAR M430 PP
K841934 · ESD
Radioear Corp.
Ear, Nose, Throat · 119d
Cleared Sep 07, 1984
AMERICAN MEDICAL OPTICS IMAGING SYS
K842127 · IYO
American Medical Optics
Radiology · 101d
Cleared Sep 07, 1984
AMIZYME-TOXOPLASMA GONDII KIT
K842528 · LGD
Amico Lab, Inc.
Microbiology · 71d
Cleared Sep 07, 1984
HOME NUTRIBAG MIXING CONTAINER 1000ML
K842628 · KPE
Medical & Pharmaceutical Supplies, Inc.
General Hospital · 63d
Cleared Sep 07, 1984
HOME NUTRIBAG MIXING CONTAINER 3000ML
K842629 · KPE
Medical & Pharmaceutical Supplies, Inc.
General Hospital · 63d
Cleared Sep 07, 1984
DIATROL BLOOD GLUCOSE TEST SYS
K842684 · CGA
Bd Becton Dickinson Vacutainer...
Chemistry · 59d
Cleared Sep 07, 1984
TERUMO SENSIBEAD EIA THYROID UPTAKE KIT
K842694 · KHQ
Terumo Medical Corp.
Chemistry · 58d
Cleared Sep 07, 1984
CARNOY'S SOLUTION
K842737 · IGM
E K Ind., Inc.
Pathology · 56d
Cleared Sep 07, 1984
ACA BARBITURATES SCREEN ANALY TEST PACK
K842783 · DIS
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 52d
Cleared Sep 07, 1984
CODE-A-WELL 350 MICROTITRATION STRIPS
K842848 · JTC
Plastic Injectors, Inc.
Chemistry · 49d
Cleared Sep 07, 1984
WRIGHT STAIN FIXATIVE
K842913 · LDZ
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
WRIGHT STAIN BUFFER
K842914 · JCC
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
SCHIFF REAGENT, PAS STAIN
K842917 · HZT
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
REES & ECKER DILUTION FLUID
K842921 · GLG
E K Ind., Inc.
Hematology · 44d
Cleared Sep 07, 1984
PICRIC ACID SATURATED SOLUTION
K842922 · LDW
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
ORANGE G, 1%
K842924 · HZH
E K Ind., Inc.
Pathology · 44d
Cleared Sep 07, 1984
HAYEM DILUTING FLUID
K842929 · GIF
E K Ind., Inc.
Hematology · 44d