FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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

Filters: Cardiovascular ×
18,151 results
13537–13560 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 02, 1988
SYSTEM5RH STATIONARY EXERCISE BICYCLE
K881475 · DPS
Combi Co. Ltd., C/O Mitsui & Co....
Cardiovascular · 117d
Cleared Aug 02, 1988
MODEL MICRO SI AMBULATORY ECG MONITOR
K881905 · DSI
Advanced Medical Products, Inc.
Cardiovascular · 88d
Cleared Aug 02, 1988
MODEL 700 PATIENT MONITOR
K882118 · DRS
Ivy Biomedical Systems, Inc.
Cardiovascular · 75d
Cleared Aug 02, 1988
MODEL #825 ADULT STIM. PADS POLYMER TYPE
K882337 · LDD
Cardiotronics, Inc.
Cardiovascular · 57d
Cleared Aug 02, 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366 · DSH
Brentwood Instruments, Inc.
Cardiovascular · 55d
Cleared Jul 28, 1988
MODIFIED PERIPHERAL DILATATION CATHETERS
K875175 · LIT
Schneider-Shilley (Usa)
Cardiovascular · 224d
Cleared Jul 28, 1988
MEDRAD OPEN ENDED GUIDEWIRE
K880332 · DQX
Medrad, Inc.
Cardiovascular · 184d
Cleared Jul 28, 1988
CORDIS PTA DILATATION CATHETERS
K880612 · LIT
Cordis Corp.
Cardiovascular · 163d
Cleared Jul 28, 1988
MODEL BPS08 BLOOD PRESSURE MODULE
K881155 · DXN
Fresenius USA, Inc.
Cardiovascular · 132d
Cleared Jul 28, 1988
HARBOR CENTRAL VENOUS CATHETER
K881884 · DQR
Harbor Medical Devices, Inc.
Cardiovascular · 85d
Cleared Jul 28, 1988
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
K881968 · DSB
Biodynamics Corp.
Cardiovascular · 78d
Cleared Jul 28, 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · DXO
Draeger Medical, Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
INTRA-ART(TM) INTERNAL MAMMARY INFUSION CATHETER
K882034 · DWF
Buckman Co., Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
HEART-CHILL SALINE SLUSH PAD
K882035 · DWJ
Buckman Co., Inc.
Cardiovascular · 73d
Cleared Jul 28, 1988
PROPAQ 104(TM)
K882085 · DSK
Protocol Systems, Inc.
Cardiovascular · 71d
Cleared Jul 28, 1988
CARDIOCAP(TM) CMO-104 MONITOR
K882093 · DSK
Datex Division Instrumentarium Corp.
Cardiovascular · 70d
Cleared Jul 28, 1988
TUNNELING STYLET
K882097 · DRB
Quinton, Inc.
Cardiovascular · 70d
Cleared Jul 28, 1988
MODEL 404 ADULT HEART RATE/BLOOD PRESSURE MONITOR
K882188 · DXN
Ivy Biomedical Systems, Inc.
Cardiovascular · 65d
Cleared Jul 28, 1988
MINIMON 7132B PATIENT MONITOR
K882198 · DPS
Kontron Instruments, Inc.
Cardiovascular · 64d
Cleared Jul 28, 1988
SLIP-COAT(TM) CATHETERS
K882796 · DQO
Cook, Inc.
Cardiovascular · 22d
Cleared Jul 27, 1988
LIFEPAK 9 DEFIBRILLATOR AND CARDIAC MONITOR
K881153 · LDD
Physio-Control Corp.
Cardiovascular · 132d
Cleared Jul 26, 1988
UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE
K881796 · DWS
Universal Medical Instrument Corp.
Cardiovascular · 90d
Cleared Jul 25, 1988
ACS HI-TORQUE STANDARD & INTERMEDI. GUIDE WIRE
K881787 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 90d
Cleared Jul 22, 1988
CHANGE TO CATHODE POWDER SPECIFICATION
K881904 · DXY
Telectronics and Cordis Pacing Systems
Cardiovascular · 77d