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
142729–142752 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 19, 1986
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
K862359 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 57d
Cleared Aug 19, 1986
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
K862364 · HEM
Swemed Laboratories, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 19, 1986
STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY
K862428 · JLW
American Dade
Chemistry · 54d
Cleared Aug 19, 1986
SUCROSEP FOLLICLE STIMULATING HORMONE (FSH) IRMA
K862439 · CGJ
Boots-Celltech Diagnostics, Inc.
Chemistry · 54d
Cleared Aug 19, 1986
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
K862453 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 53d
Cleared Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
K862525 · JIT
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Aug 19, 1986
SERACON(TM) CAL (PRODUCT NO. DO35)
K862594 · JIX
Bhp Diagnostix, Inc.
Chemistry · 42d
Cleared Aug 19, 1986
DOUBLE ANTIBODY ESTRADIOL RIA KIT
K862603 · CHP
Diagnostic Products Corp.
Chemistry · 42d
Cleared Aug 19, 1986
SERATEST ENA [SS-B] KIT
K862700 · LLL
Hemagen Diagnostics, Inc.
Immunology · 35d
Cleared Aug 19, 1986
SURESPOT
K862701 · JQW
Helena Laboratories
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
K862704 · JIS
Em Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
K862706 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
K862707 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 34d
Cleared Aug 19, 1986
V-TREND QC TDM CONTROL SERUM 1,2,3.
K862817 · DIF
Texas Immunology, Inc.
Toxicology · 26d
Cleared Aug 19, 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K862818 · JJE
American Dade
Chemistry · 26d
Cleared Aug 19, 1986
MODEL 303-47/303-48 ALANINE AMINOTRANSFERASE KIT
K862833 · CKA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
MODEL 115-16 PHOSPHORUS (UV) ASSAY KIT
K862834 · CEO
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 25d
Cleared Aug 19, 1986
RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOL
K862871 · CGR
Cambridge Medical Technology
Chemistry · 21d
Cleared Aug 19, 1986
HOLLISTER FEMALE URINARY COLLECTION POUCH
K862934 · KNX
Hollister, Inc.
Gastroenterology & Urology · 15d
Cleared Aug 19, 1986
ICON READER
K862956 · JQT
Hybritech, Inc.
Chemistry · 14d
Cleared Aug 19, 1986
ANTIASTHMATIC CALIBRATORS
K862964 · DLJ
American Monitor Corp.
Toxicology · 13d
Cleared Aug 19, 1986
ASTRA 2,3,4 AND 6: CHIP REVISION
K863000
Cardiac Pacemakers, Inc.
Cardiovascular · 11d
Cleared Aug 19, 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
K863002 · JGJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Aug 19, 1986
CERVICAL SCRAPERS
K863145 · HHT
Surgipath Medical Industries, Inc.
Obstetrics & Gynecology · 4d