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
13417–13440 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 29, 1988
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593 · DPW
Cardio Metrics, Inc.
Cardiovascular · 66d
Cleared Aug 25, 1988
VESSEL DILATOR AND INTRODUCER SHEATH
K882238 · DRE
Ideal Medical, Inc.
Cardiovascular · 90d
Cleared Aug 25, 1988
METATECH MICROCLIP APPLICATOR
K882367 · DWS
Metatech Corp.
Cardiovascular · 78d
Cleared Aug 25, 1988
MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
K882452 · DTB
Medtronic Vascular
Cardiovascular · 72d
Cleared Aug 19, 1988
3000 PHYSIOLOGICAL MONITOR
K880301 · DXG
Datascope Corp.
Cardiovascular · 207d
Cleared Aug 19, 1988
COATING FOR WIRE GUIDE
K880722 · DQX
Cook, Inc.
Cardiovascular · 178d
Cleared Aug 19, 1988
TAPER-22 STEERABLE GUIDEWIRE
K880761 · DQX
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762 · DQX
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
ECG MONITOR AND RESPIRATION PACER
K881055 · DPS
D. E. Hokanson, Inc.
Cardiovascular · 164d
Cleared Aug 19, 1988
EXTERNAL PACEMAKER 2000 (EP2000)
K882168 · DRO
Unomed, Inc.
Cardiovascular · 87d
Cleared Aug 12, 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · DXO
Ohmeda Medical
Cardiovascular · 164d
Cleared Aug 12, 1988
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER
K881723 · JOP
Biosound, Inc.
Cardiovascular · 113d
Cleared Aug 12, 1988
EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40
K882137 · DTM
Medtronic Blood Systems, Inc.
Cardiovascular · 84d
Cleared Aug 12, 1988
MINIMON 7131B PATIENT MONITOR
K882197 · DPS
Kontron Instruments, Inc.
Cardiovascular · 79d
Cleared Aug 12, 1988
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · DYB
Argon Medical Corp.
Cardiovascular · 78d
Cleared Aug 11, 1988
INTERSEPT* OXYGEN GAS LINE FILTER
K882136 · KRD
Medtronic Blood Systems, Inc.
Cardiovascular · 83d
Cleared Aug 09, 1988
NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS
K875127 · DQO
Novoste Corp.
Cardiovascular · 238d
Cleared Aug 08, 1988
TELSTETH TELEMETRIC STETHOSCOPE(TM)
K882119 · DXH
Quantsonics, Inc.
Cardiovascular · 81d
Cleared Aug 04, 1988
CORONARY VEIN GRAFT MARKER
K882314 · DSY
Med-Edge, Inc.
Cardiovascular · 62d
Cleared Aug 03, 1988
ACS HI-TORQUE FLOPPY/FLOPPY II/INTER./STANDARD GW
K881897 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 89d
Cleared Aug 02, 1988
OMNIGRAPH 6000
K880357 · DPS
Telemed Div.
Cardiovascular · 187d
Cleared Aug 02, 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 174d
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