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
172441–172464 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 19, 1977
ROCHE AXISCAN 5
K771816 · HEM
Roche Medical Electronics, Inc.
Obstetrics & Gynecology · 22d
Cleared Oct 19, 1977
ENZYMATIC CHOLESTEROL
K771820 · CHH
Macomb Chemical Co.
Chemistry · 26d
Cleared Oct 19, 1977
BG II ANALYZER
K771822 · CHL
Technicon Instruments Corp.
Hematology · 27d
Cleared Oct 19, 1977
MEDPRO FLOTATION SYSTEM
K771824 · IKY
Medpro, Inc.
General Hospital · 22d
Cleared Oct 19, 1977
TOTAL BILIRUBIN
K771840 · CIG
Gamma Enterprises, Inc.
Chemistry · 28d
Cleared Oct 19, 1977
AUTOMIXER, KODAK
K771857 · IXW
Eastman Kodak Company
Radiology · 20d
Cleared Oct 19, 1977
GLYCOPROTEIN TEST, LAS-R HUMAN 1-ACID
K771879 · DEN
Hyland Therapeutic Div., Travenol...
Immunology · 15d
Cleared Oct 19, 1977
EMI FOUR
K771902 · IYE
Emi Therapy Systems, Inc.
Radiology · 13d
Cleared Oct 19, 1977
LAS-R BETA LIPOPROTEIN TEST
K771912 · DFC
Hyland Therapeutic Div., Travenol...
Immunology · 8d
Cleared Oct 19, 1977
PROCEDURE NO. 555
K771916 · CGX
Sigma Chemical Co.
Chemistry · 8d
Cleared Oct 18, 1977
HEMATRAK RBC MORPHOLOGY
K761207 · GKZ
Geometric Data, Div. Smithkline Corp.
Hematology · 315d
Cleared Oct 18, 1977
URI-DRAIN COMBO KIT FOR MALE INCONTINENC
K770789 · KNX
Chesebrough-Pond'S U.S.A. Co.
Gastroenterology & Urology · 168d
Cleared Oct 18, 1977
CATHETER, URETHERAL
K770814 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 168d
Cleared Oct 18, 1977
ENDOSCOPE, UROLOGICAL, FEMALE
K770943 · FAL
C.R. Bard, Inc.
Gastroenterology & Urology · 146d
Cleared Oct 18, 1977
SURGICAL STAPLING INSTRU., AUTO, SUTURE
K771177 · GAG
United States Surgical, A Division of...
General & Plastic Surgery · 110d
Cleared Oct 18, 1977
DISP. LOADING UNIT, AUTO, SUTURE
K771178 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 110d
Cleared Oct 18, 1977
TSH RIA REAGENT SET
K771234 · JLW
G.D. Searle and Co.
Chemistry · 99d
Cleared Oct 18, 1977
ELECTROPHORESIS POWER SUPPLY TESTER
K771322 · JJN
Corning Medical & Scientific
Chemistry · 92d
Cleared Oct 18, 1977
I.L. MODEL 643 FLAME PHOTOMETER
K771337 · JJO
Instrumentation Laboratory CO
Chemistry · 91d
Cleared Oct 18, 1977
IFA ANTI-NDNA
K771376 · DHN
Electro-Nucleonics Laboratories, Inc.
Immunology · 85d
Cleared Oct 18, 1977
NEO TSH-RIA KIT
K771378 · JLW
Nuclear Medical Systems, Inc.
Chemistry · 90d
Cleared Oct 18, 1977
TENCKHOFF PERITONEAL TUBING ADAPT.
K771428 · FKY
Quinton, Inc.
Gastroenterology & Urology · 78d
Cleared Oct 18, 1977
STAT/LYTE ANALYZER
K771592 · JFL
Technicon Instruments Corp.
Chemistry · 60d
Cleared Oct 18, 1977
ELECTROCARDIOGRAPHIC CABLHS & LEAD WIRE
K771645 · DSA
Tronomed, Inc.
Cardiovascular · 50d