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
146425–146448 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1985
FETAL BOVINE/FETAL CALF SERUM, NEWBORN, HORSE, RAB
K853803 · KIS
Z.L. Bocknek Laboratories, Inc.
Pathology · 34d
Cleared Oct 15, 1985
VISION THEOPHYLLINE
K853834 · KLS
Abbott Laboratories
Toxicology · 29d
Cleared Oct 15, 1985
SUPER MICRO BLADES
K853847
Kdans Surgical, Inc.
General & Plastic Surgery · 29d
Cleared Oct 15, 1985
XTAL X-150 OPERATING MICROSCOPE
K853855 · HRM
Xtal Corp.
General & Plastic Surgery · 29d
Cleared Oct 15, 1985
IL TEST THEOPHYLLINE ASSAY
K853858 · KLS
Allied Instrumentation Laboratory
Toxicology · 29d
Cleared Oct 15, 1985
PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO
K853865 · CDZ
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS
K853866 · CHP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 28d
Cleared Oct 15, 1985
AMRESCO FLOW PAC CREATININE COLOR REAGENT 2310 &
K853888 · CGX
American Research Products Co.
Chemistry · 26d
Cleared Oct 15, 1985
ALL KINDS OF SUNGLASSES
K853921 · HQY
Winsburn Company , Ltd.
Ophthalmic · 22d
Cleared Oct 15, 1985
TDX AMYLASE
K853978 · CIX
Abbott Laboratories
Chemistry · 19d
Cleared Oct 15, 1985
ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP
K854009 · DJP
Roche Diagnostic Systems, Inc.
Toxicology · 15d
Cleared Oct 11, 1985
IPG-300
K852238 · DSB
Thornton Associates, Inc.
Cardiovascular · 141d
Cleared Oct 11, 1985
ANGIOMEDICS SOFTIP CATHETER
K852872 · DQO
Angiomedics, Inc.
Cardiovascular · 95d
Cleared Oct 11, 1985
PACEPAC
K852958 · DRO
Medical Data Electronics
Cardiovascular · 91d
Cleared Oct 11, 1985
SHILEY CSD EXTENSION LINE WITH FILTER
K852984 · DWF
Shiley, Inc.
Cardiovascular · 88d
Cleared Oct 11, 1985
WILLIAM HARVEY HYBID OXYGENATOR H-1700
K853080 · DTZ
C.R. Bard, Inc.
Cardiovascular · 80d
Cleared Oct 11, 1985
BIO PACK MODEL 200
K853126 · DWA
Bio Medicus, Inc.
Cardiovascular · 78d
Cleared Oct 11, 1985
FUKUDA DENSHI MODEL/DS-1030A DYNASCOPE SERIES MON
K853213 · DSI
Fukuda Denshi USA, Inc.
Cardiovascular · 144d
Cleared Oct 11, 1985
CARDIO DATA PACERECORDER PR3
K853262 · DSH
Cardio Data
Cardiovascular · 67d
Cleared Oct 11, 1985
MEDIC 4
K853354 · LDD
Kone Instruments, Inc.
Cardiovascular · 60d
Cleared Oct 11, 1985
MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD
K853410 · DTR
Intermedics, Inc.
Cardiovascular · 59d
Cleared Oct 11, 1985
MODEL 43130A DEFIBRILLATOR
K853439 · LDD
Hewlett-Packard Co.
Cardiovascular · 56d
Cleared Oct 11, 1985
LIFEPAK 200
K853564 · MKJ
Physio-Control Corp.
Cardiovascular · 46d
Cleared Oct 11, 1985
MEDTRONIC MODEL 6405
K853818 · LDF
Medtronic Vascular
Cardiovascular · 29d