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
166753–166776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 29, 1980
CARDIACS II TOXICOLOGY CONTROL
K800884 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
BARBITURATES TOXICOLOGY CONTROL
K800885 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL
K800886 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
HYPNOTICS PLUS SALICYLATE TX CONTROL
K800887 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
TRICYCLIC ANTIDEPRESSANT II TX CONTROL
K800889 · DIF
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Apr 29, 1980
PREMIER TRIPLE TRAY
K800900 · EHY
Premier Dental Products Co.
Dental · 11d
Cleared Apr 29, 1980
GAL-PUT CONTROLS, NORMAL&DEFICIENT
K800910 · JIX
Sigma Chemical Co.
Chemistry · 8d
Cleared Apr 28, 1980
ADT BONE MAR. BIO/ASP. TRAY W/NEEDLE
K800408 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT BONE MARROW BIOPSY ASPIRATION TRAY
K800409 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT BONE MARROW BIOPSY-ASPIRATION TRAY
K800410 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ASPIRATION TRAY W/FERRIS DISP. ILLINOIS
K800411 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ROSENTHAL NEEDLE (DISP.) ADT BONE MARROW
K800412 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT SOFT TISSUE BIOPSY TRAY
K800414 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT PTC PRO. TRAY W/(SKINNY CHIBA) NEEDL
K800417 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 28, 1980
ADT DISPOSABLE THIN NEEDLE ASPIRATION
K800418 · FSM
A.D.T. Lab Industries
General & Plastic Surgery · 62d
Cleared Apr 24, 1980
FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.
K800147 · KRH
Usifroid
Cardiovascular · 93d
Cleared Apr 24, 1980
MEDSPEC OPERATIVE OPTHALMIC KIT
K800404 · HMP
Medi-Spec
General & Plastic Surgery · 58d
Cleared Apr 24, 1980
GEMENI IGM ASSAY
K800450 · DAO
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Apr 24, 1980
GEMENI IGG ASSAY
K800451 · DEW
Electro-Nucleonics Laboratories, Inc.
Immunology · 55d
Cleared Apr 24, 1980
GAMMA STICK GENTAMICIN RIA KIT
K800537 · DJB
Alpha Gamma Laboratory
Toxicology · 45d
Cleared Apr 24, 1980
GAMMA STICK CORTISOL RIA KIT/STICK KIT
K800538 · CGR
Alpha Gamma Laboratory
Chemistry · 45d
Cleared Apr 24, 1980
SINGLE, 2&3 WAY SOLUTION SETS #14-070 ET
K800618 · DQO
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
THERMODILUTION CATHETER INTRO. KIT
K800619 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d
Cleared Apr 24, 1980
VENOUS M/A INTERNAL JUGULAR KIT
K800620 · DYB
Norton Performance Plastics Corp.
Cardiovascular · 37d