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
147625–147648 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1985
DADE BLOOD GAS AMPUL INJECTOR
K852285 · JQW
American Dade
Chemistry · 41d
Cleared Jul 09, 1985
DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST
K852286 · JHJ
Sero-Immuno Diagnostics, Inc.
Chemistry · 41d
Cleared Jul 09, 1985
TERUMO SENSIBEAD EIA HGH KIT
K852299 · CFL
Terumo Medical Corp.
Chemistry · 41d
Cleared Jul 09, 1985
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
K852320 · LAR
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Jul 09, 1985
DIG RADIOIMMUNOASSAY TEST SYSTEM
K852343 · DNL
M Nobird, Inc.
Toxicology · 36d
Cleared Jul 09, 1985
SIMULTANEOUS LH/FSH SYSTEM BY RIA
K852376 · CEP
American Bioclinical, Inc.
Chemistry · 35d
Cleared Jul 09, 1985
DERM-KIT
K852480 · JSI
Culture Kits, Inc.
Microbiology · 28d
Cleared Jul 09, 1985
3M FUKUDA TYPE RING RETRACTOR
K852567 · GAD
3M Company
General & Plastic Surgery · 21d
Cleared Jul 09, 1985
RUBIN DISPOSABLE CARTILAGE PLANNER
K852577
Frank F. Rubin
General & Plastic Surgery · 21d
Cleared Jul 09, 1985
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420
K852725 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Jul 09, 1985
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420
K852726 · KOA
The Huxley Instrument Corp.
Gastroenterology & Urology · 13d
Cleared Jul 08, 1985
TRINDIUM-DENTAL MATERIAL
K850084 · EJH
Trindium Corp. of America
Dental · 179d
Cleared Jul 08, 1985
CYBERMEDIC CM-810 BODY PLETHYSMOGRAPH
K851197 · JEH
Cybermedic, Inc.
Anesthesiology · 104d
Cleared Jul 08, 1985
LEGIONELLA CULTURE CONFIRMATIN KIT
K851271 · GRO
Gen-Probe, Inc.
Microbiology · 98d
Cleared Jul 08, 1985
BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)
K851415 · DSB
Medi-Sport Testing, Inc.
Cardiovascular · 90d
Cleared Jul 08, 1985
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · CAF
Invacare Corp.
Anesthesiology · 89d
Cleared Jul 08, 1985
LPA-3 PRINTER
K851805 · BZC
Life Products, Inc.
Anesthesiology · 69d
Cleared Jul 08, 1985
LPA-2 REMOTE ALARM
K851905 · CAP
Life Products, Inc.
Anesthesiology · 69d
Cleared Jul 08, 1985
RESUS-AID DISPOSABLE RESUSCITATION SHIELD
K852096 · BTM
Emergency Situation Products
Anesthesiology · 55d
Cleared Jul 08, 1985
BIVONA TRACHEOSTOMA VALVE II
K852272 · BTO
Bivona Medical Technologies
Anesthesiology · 41d
Cleared Jul 08, 1985
DURAZYME UREA NITROGEN
K852292 · CDQ
American Monitor Corp.
Chemistry · 40d
Cleared Jul 08, 1985
HDL CHOLESTEROL PRETREATMENT
K852350 · LBR
American Monitor Corp.
Chemistry · 38d
Cleared Jul 08, 1985
ANDROS ANALYZERS AIRWAY ADAPTER
K852463 · CCK
Andros Analyzers, Inc.
Anesthesiology · 28d
Cleared Jul 08, 1985
UNCUFFED HI-LO JET TRACHEAL TUBE
K852493 · BTR
Mallinckrodt Critical Care
Anesthesiology · 26d