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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
114817–114840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1993
DISPOSABLE VASCULAR ANGIOSCOPE
K923996 · LYK
Endovascular, Inc.
Cardiovascular · 156d
Cleared Jan 13, 1993
FAST DIGOXIN TEST SYSTEM
K924504 · KXT
Diatron Corp.
Toxicology · 131d
Cleared Jan 13, 1993
HDL-CHOLESTEROL STANDARD, MODIFICATION
K924904 · JIS
Verichem Laboratories, Inc.
Chemistry · 106d
Cleared Jan 13, 1993
PRO-STEP HCG
K925125 · JHI
Disease Detection International, Inc.
Chemistry · 92d
Cleared Jan 13, 1993
UROLOGICAL CATHETER AND ACCESSORIES
K925282 · FAD
Applied Urology, Inc.
Gastroenterology & Urology · 85d
Cleared Jan 13, 1993
IMX PAP
K925377 · JFH
Abbott Laboratories
Chemistry · 82d
Cleared Jan 13, 1993
KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
K925748 · GBX
Kendall Healthcare Products Co....
General & Plastic Surgery · 61d
Cleared Jan 13, 1993
ACCESS DIGOXIN ASSAY
K925802 · KXT
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Jan 13, 1993
IMMULITE FERRITIN
K925848 · JMG
Diagnostic Products Corp.
Immunology · 56d
Cleared Jan 13, 1993
ACCESS FERRITIN ASSAY
K926221 · JMG
Bio-Rad Laboratories, Inc.
Immunology · 34d
Cleared Jan 12, 1993
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · BZE
Baxter Healthcare Corp
Anesthesiology · 419d
Cleared Jan 12, 1993
HEXLOCK SCREW
K920909 · DZE
Imtec Corp.
Dental · 320d
Cleared Jan 12, 1993
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910 · BTL
J. H. Emerson Co.
Anesthesiology · 320d
Cleared Jan 12, 1993
THE DENVER CAUTERY
K922062 · GEI
Denver Splint Co.
General & Plastic Surgery · 253d
Cleared Jan 12, 1993
TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER
K922308 · FTM
Ti-Mesh, Inc.
General & Plastic Surgery · 242d
Cleared Jan 12, 1993
ALM ILLUMINATOR SERIES LIGHT SYSTEM
K922409 · FSQ
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 236d
Cleared Jan 12, 1993
ON*SITE ALCOHOL
K923337 · DML
Toxi-Lab, Inc.
Toxicology · 208d
Cleared Jan 12, 1993
GUIDING CATHETER
K923518 · DQY
Interventional Therapeutics Corp.
Cardiovascular · 182d
Cleared Jan 12, 1993
INLET IRRIGATION/ASPIRATION VALVE AND PROBES
K923528 · GCJ
Inlet Medical, Inc.
General & Plastic Surgery · 180d
Cleared Jan 12, 1993
3DTOF MRA
K923870 · LNH
Resonex, Inc.
Radiology · 162d
Cleared Jan 12, 1993
ACCUFLATE
K924273 · KCY
Instrumed, Inc.
General & Plastic Surgery · 141d
Cleared Jan 12, 1993
TURKEL ABDOMINAL PARACENTESIS SYSTEM
K924702 · GBX
Symbiosis Corp.
General & Plastic Surgery · 117d
Cleared Jan 12, 1993
EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS
K925186 · KPS
Strichman Medical Equipment, Inc.
Radiology · 90d
Cleared Jan 12, 1993
BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED
K925204 · LCP
Beckman Instruments, Inc.
Hematology · 98d