FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
13993–14016 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jun 24, 1987
PULSE/B.P. MONITOR
K864411 · DXN
Pulse Time Products, Ltd.
Cardiovascular · 229d
Cleared Jun 24, 1987
CATHETER INTRODUCER
K871153 · DYB
Angeion Corp.
Cardiovascular · 92d
Cleared Jun 24, 1987
STAT-PAD (TM)
K871538 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 65d
Cleared Jun 24, 1987
MODIFIED MODEL UA-711 DIGITAL SPHYGMONOMETER
K871718 · DSK
A&D Engineering, Inc.
Cardiovascular · 51d
Cleared Jun 24, 1987
STAT-VAC CHEST DRAINAGE SYSTEM
K871775 · DTN
Gish Biomedical, Inc.
Cardiovascular · 49d
Cleared Jun 24, 1987
FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)
K871944 · DSH
Futurecare Systems, Inc.
Cardiovascular · 36d
Cleared Jun 24, 1987
MODIFIED PACE*AID MODEL 53
K871971 · DRO
Cardiac Resucitator Corp.
Cardiovascular · 34d
Cleared Jun 24, 1987
MODEL 5600B PROGRAMMER, PACEMAKER
K871986 · KRG
Telectronics, Inc.
Cardiovascular · 33d
Cleared Jun 19, 1987
40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER
K864537 · DSP
Aries Medical, Inc.
Cardiovascular · 214d
Cleared Jun 19, 1987
40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER
K864994 · DSP
Aries Medical, Inc.
Cardiovascular · 179d
Cleared Jun 19, 1987
PREDICTOR
K871436 · DQK
Corazonix Corp.
Cardiovascular · 67d
Cleared Jun 19, 1987
EASY READ(TM)
K871794 · DXN
Health O Meter
Cardiovascular · 43d
Cleared Jun 19, 1987
UMSC HOLTER MONITORING KIT
K872087 · DSH
United Medical Supply Co., Inc.
Cardiovascular · 18d
Cleared Jun 18, 1987
GEM-CRIT CHECK
K871686 · DRY
Diamond Sensor Systems
Cardiovascular · 50d
Cleared Jun 16, 1987
LP-3 ELECTROCARDIOGRAPH
K864614 · DPS
Fidelity Medical, Inc.
Cardiovascular · 204d
Cleared Jun 16, 1987
MODEL 617 CARDIAC OUTPUT COMPUTER
K870375 · DXG
Omnimed B.V.
Cardiovascular · 138d
Cleared Jun 16, 1987
GUIDING CATHETERS 9F JL4
K871021 · DQO
Devices For Vascular Intervention, Inc.
Cardiovascular · 92d
Cleared Jun 15, 1987
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
K871596 · DTJ
Shiley, Inc.
Cardiovascular · 52d
Cleared Jun 12, 1987
PULSE CUFF RECORDER MODEL PCR100
K863702 · JOM
Imex Medical Systems, Inc.
Cardiovascular · 262d
Cleared Jun 12, 1987
TATCH-IT
K870356 · DRS
Reunion Medical Co.
Cardiovascular · 134d
Cleared Jun 12, 1987
DIGITAL SPHYGMOMANOMETER
K871371 · DRS
Omron Tateisi Electronics Co.
Cardiovascular · 66d
Cleared Jun 12, 1987
CARDIO-MEGA SYSTEM
K871890 · DSI
Grandcor Medical Systems
Cardiovascular · 28d
Cleared Jun 10, 1987
DS-II DIGITAL SONOGRAPHY SYSTEM
K864278 · DQD
Intl. Acoustics, Inc.
Cardiovascular · 223d
Cleared Jun 10, 1987
BIODAN TYPE COMET ELECTRODE
K871668 · DRX
National Medical Technology
Cardiovascular · 43d