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
141217–141240 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 07, 1987
DUOCEPH
K864527 · IWY
Gary E. Hall, Dds
Radiology · 51d
Cleared Jan 07, 1987
EASY-TEST PRIMIDONE ITEM NO. 67---/95
K864554 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 49d
Cleared Jan 07, 1987
TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP
K864677 · JLW
Serono Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 07, 1987
EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95
K864925 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 07, 1987
EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95
K864926 · DLZ
Em Diagnostic Systems, Inc.
Toxicology · 22d
Cleared Jan 06, 1987
SPERM CAPACITATION MEDIUM
K861188 · HDR
Irvine Scientific
Obstetrics & Gynecology · 281d
Cleared Jan 06, 1987
ANGIOTOPO CATHETER
K861241 · DQO
Houston Biomedical, Inc.
Cardiovascular · 279d
Cleared Jan 06, 1987
MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
K862051 · DTB
Intermedics, Inc.
Cardiovascular · 222d
Cleared Jan 06, 1987
CANWEST OVU-BLUE
K862055 · CEP
Canwest Medictex, Inc.
Chemistry · 221d
Cleared Jan 06, 1987
MODIFICATION OF CARDIOINTEGRAM/CARDIOINTEGRAPH
K863153 · DXG
Ocg Technology, Inc.
Cardiovascular · 144d
Cleared Jan 06, 1987
MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG ELECTRODES
K863369 · DRX
Tdk Corp.
Cardiovascular · 166d
Cleared Jan 06, 1987
LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD.
K863535 · DPS
Computerized Medical Systems, Inc.
Cardiovascular · 117d
Cleared Jan 06, 1987
MEDTRONIC MODEL 5013
K863536 · DTB
Medtronic Vascular
Cardiovascular · 117d
Cleared Jan 06, 1987
URESIL SUBCLAVIAN CATHETER
K863684 · DQY
Uresil Corp.
Cardiovascular · 109d
Cleared Jan 06, 1987
COMPUTER CONTROLLED EXTENSION (CCX)
K863705 · IYE
Varian Assoc., Inc.
Radiology · 105d
Cleared Jan 06, 1987
ACCUSAT
K863855 · DQA
Datascope Corp.
Anesthesiology · 96d
Cleared Jan 06, 1987
DISPOSABLE ECG MONITORING ELECTRODE
K863904 · DRX
Clinical Data, Inc.
Cardiovascular · 91d
Cleared Jan 06, 1987
MODIFICATION TO DYNASCOPE SERIES MONITORS
K863914 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM
K863916 · DQY
Cardio-Vascular Innovations, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.
K863917 · DYB
Cardio-Vascular Innovations, Inc.
Cardiovascular · 90d
Cleared Jan 06, 1987
DUFFY BOLUS INJECTOR
K863936 · IWR
Viox Corp.
Radiology · 89d
Cleared Jan 06, 1987
PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED)
K864062 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 78d
Cleared Jan 06, 1987
PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
K864153 · DTB
Pace Medical
Cardiovascular · 75d
Cleared Jan 06, 1987
SHEAR FORCE GAUGE
K864330 · DXE
American Edwards Laboratories
Cardiovascular · 63d