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: Cardiovascular ×
18,053 results
16057–16080 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448 · DTB
Oscor, Inc.
Cardiovascular · 17d
Cleared Nov 30, 1982
MEDTRONIC MODELS 4011 & 4511
K822781 · DTB
Medtronic Vascular
Cardiovascular · 77d
Cleared Nov 30, 1982
THE 500 MONITOR SERIES
K823052 · DXN
Vitatek
Cardiovascular · 43d
Cleared Nov 30, 1982
INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT
K823108 · DTM
Extracorporeal Medical Specialities,...
Cardiovascular · 40d
Cleared Nov 30, 1982
CADIO-RESPIRATORY MONITOR #CR-2
K823312 · DRT
Electromed Intl., Ltd.
Cardiovascular · 25d
Cleared Nov 30, 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · DYG
Critikon Company, LLC
Cardiovascular · 14d
Cleared Nov 30, 1982
MIKRO-TIP CATHETER PRESSURE TRANSDUCER
K823434 · DRF
Millar Instruments, Inc.
Cardiovascular · 14d
Cleared Nov 24, 1982
PRESS-O-TEST
K822102 · DXN
Medi-Swiss Corp.
Cardiovascular · 131d
Cleared Nov 24, 1982
MODEL 366-07 ADAPT AID LEAD ADAPTER
K822704 · DTD
Intermedics, Inc.
Cardiovascular · 78d
Cleared Nov 24, 1982
MODEL LS-85 & MEDEL 1828 LINESCAN VISCO
K822926
Honeywell, Inc.
Cardiovascular · 54d
Cleared Nov 24, 1982
MINGOCARD 7 & MINGOPHONE 7
K822983 · DSF
Siemens Corp.
Cardiovascular · 47d
Cleared Nov 24, 1982
CAPIOX II
K823125 · DTZ
Terumo Medical Corp.
Cardiovascular · 30d
Cleared Nov 24, 1982
EXV VENOUS RESERVOIR BAG & HOLDER
K823205 · DTN
Extracorporeal Medical Specialities,...
Cardiovascular · 28d
Cleared Nov 24, 1982
MODEL 525 NEO-TRAK NEONATAL RECORDER
K823210 · DSF
Ge Medical Systems Information...
Cardiovascular · 27d
Cleared Nov 24, 1982
CKG 8800
K823215 · DSB
Cardio Kinetics, Inc.
Cardiovascular · 27d
Cleared Nov 24, 1982
COSMOS
K823220 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 23d
Cleared Nov 24, 1982
LIFESCOPE II/FOUR
K823249 · DRG
Nihon Kohden America, Inc.
Cardiovascular · 23d
Cleared Nov 24, 1982
INTERFACE ARTERIAL BLOOD FILTER #40
K823258 · DTM
Medical, Inc.
Cardiovascular · 22d
Cleared Nov 24, 1982
INTERFACE CARDIOTOMY BLOOD FILTER #50
K823259 · JOD
Medical, Inc.
Cardiovascular · 22d
Cleared Nov 24, 1982
INTERFACE CARDIOTOMY BLOOD FILTER #51
K823260 · JOD
Medical, Inc.
Cardiovascular · 22d
Cleared Nov 17, 1982
ROTARY VASCULAR KNIFE
K822829 · DWS
Medco Products, Co., Inc.
Cardiovascular · 57d
Cleared Nov 03, 1982
HOLTER RECORDER
K822970 · DSH
Agilent Technologies
Cardiovascular · 26d
Cleared Nov 01, 1982
SARNS PULSATILE PUMP
K820729 · DWB
3M Health Care, Sarns
Cardiovascular · 229d
Cleared Nov 01, 1982
WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD
K821477 · DTZ
C.R. Bard, Inc.
Cardiovascular · 167d