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
139873–139896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1987
T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KIT
K870573 · CDX
Cambridge Medical Technology
Chemistry · 71d
Cleared Apr 22, 1987
CHLORIDE TEST
K870630 · CHJ
Sclavo, Inc.
Chemistry · 68d
Cleared Apr 22, 1987
OMEGA T100
K870666 · GZJ
Henley Intl.
Neurology · 62d
Cleared Apr 22, 1987
OMEGA T200
K870667 · GZJ
Henley Intl.
Neurology · 62d
Cleared Apr 22, 1987
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · GRM
Armkel, LLC
Microbiology · 50d
Cleared Apr 22, 1987
CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
K870928 · CHH
Electro-Nucleonics Laboratories, Inc.
Chemistry · 44d
Cleared Apr 22, 1987
WATERS 650 ADVANCED PROTEIN PURIFICATION SYSTEM
K870949 · LDM
Millipore Corp.
Chemistry · 43d
Cleared Apr 22, 1987
DISPOSABLE, PIN-CONN. POLYMER-GEL ELECT. FOR TENS
K871026 · GXY
Labeltape Meditect, Inc.
Neurology · 37d
Cleared Apr 22, 1987
ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER
K871140 · DYB
Aries Medical, Inc.
Cardiovascular · 30d
Cleared Apr 22, 1987
URESIL CAROTID ARTERY SIZERS
K871148 · DRE
Uresil Corp.
Cardiovascular · 30d
Cleared Apr 22, 1987
ENZYMATIC TRIGLYCERIDES GPO-TRINDER METHOD
K871301 · CDT
American Monitor Corp.
Chemistry · 21d
Cleared Apr 22, 1987
TITAN GEL MULTI-SLOT LIPO-17 SYSTEM
K871319 · JHO
Helena Laboratories
Chemistry · 19d
Cleared Apr 22, 1987
FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
K871320 · CDW
American Research Products Co.
Chemistry · 19d
Cleared Apr 22, 1987
FLOW-PAC INORGANIC PHOSPHORUS REAGENTS
K871321 · CEO
American Research Products Co.
Chemistry · 19d
Cleared Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
K871330 · DLJ
Em Diagnostic Systems, Inc.
Toxicology · 19d
Cleared Apr 22, 1987
QM300 IGG ANTIBODY PACK
K871340 · DEW
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 20d
Cleared Apr 22, 1987
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS
K871352 · DEW
Helena Laboratories
Immunology · 16d
Cleared Apr 22, 1987
MICROPLATE LUMINOMETER ML 1000 (NO. 012-101-000)
K871415 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 14d
Cleared Apr 22, 1987
COLORIMETRIC URIC ACID REAGENT SET
K871417 · KNK
Biochemical Trade, Inc.
Chemistry · 15d
Cleared Apr 21, 1987
RAPID AS LATEX
K862530 · GTQ
Dilab, Inc.
Microbiology · 293d
Cleared Apr 21, 1987
CHROMAGEN TEST FOR GROUP D ENTEROCOCCUS
K870410 · JTO
Diversified Diagnostic Industries
Microbiology · 77d
Cleared Apr 21, 1987
GEN-PROBE BETA-LACTAMASE TEST KIT
K870422 · JTO
Gen-Probe, Inc.
Microbiology · 77d
Cleared Apr 21, 1987
CHROMAGEN TEST FOR GRAM (+) & (-) DIFFERENTIATION
K870561 · JTO
Diversified Diagnostic Industries
Microbiology · 70d
Cleared Apr 21, 1987
O.1 TO 25.0% CARB. DIOX. U.S.P. BALANCE OXYGEN USP
K871100 · BXK
Matheson Gas Products, Inc.
Anesthesiology · 33d