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
14521–14544 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 31, 1986
PRODIGY AND PRODIGY PLUS
K860167 · DSI
Cardiodata Corp.
Cardiovascular · 73d
Cleared Mar 31, 1986
AMI CARDIO-PAD
K860283 · DRO
Andover Medical, Inc.
Cardiovascular · 62d
Cleared Mar 31, 1986
TUBING CONNECTORS
K860291 · DTL
Biomedical Exports, Inc.
Cardiovascular · 62d
Cleared Mar 31, 1986
PERCUTANEOUS CATHETERS
K860339 · DQY
Micor, Inc.
Cardiovascular · 61d
Cleared Mar 31, 1986
PERCUTANEOUS INTRODUCER KIT
K860432 · DYB
Cormed, Inc., Sub. C.R.Bard, Inc.
Cardiovascular · 55d
Cleared Mar 31, 1986
(.O38) HI-TORQUE GUIDE WIRES
K860533 · DQX
Target Therapeutics
Cardiovascular · 47d
Cleared Mar 31, 1986
ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE
K860570 · KRA
Parke-Davis Co.
Cardiovascular · 45d
Cleared Mar 31, 1986
ACS BRACHIAL CORONARY GUIDING CATH W/TAPERED TIP
K860580 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 41d
Cleared Mar 31, 1986
REGULATED PRESSURE INJECTOR
K860806 · DXF
Target Therapeutics
Cardiovascular · 27d
Cleared Mar 31, 1986
MODEL 366-08 ADAPTAID CONNECTOR ADAPTER
K860832 · DTD
Intermedics, Inc.
Cardiovascular · 26d
Cleared Mar 31, 1986
MODEL 366-19 ADAPTAID ADAPTER SLEEVE
K860985 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 31, 1986
MODEL 366-09 ADAPTAID ADAPTER SLEEVE
K860986 · DTB
Intermedics, Inc.
Cardiovascular · 14d
Cleared Mar 26, 1986
NORELCO ELECTRONIC DIGITAL BP METER HC3501
K854023 · DXQ
Philips Park
Cardiovascular · 177d
Cleared Mar 26, 1986
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125 · DRT
Honeywell, Inc.
Cardiovascular · 93d
Cleared Mar 25, 1986
CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM
K855229 · DXK
Vingmed, Inc.
Cardiovascular · 85d
Cleared Mar 21, 1986
LITTON DATAMEDIX BLOOD PRESSURE MONITOR NI
K853599 · DXN
Litton Datamedix
Cardiovascular · 206d
Cleared Mar 17, 1986
MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS
K855147 · DXY
Medtronic Vascular
Cardiovascular · 83d
Cleared Mar 13, 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · DXN
Welch Allyn, Inc.
Cardiovascular · 268d
Cleared Mar 13, 1986
PE-3000 PULSE RATE MONITOR
K854198 · DRT
Quantum Life Systems, Inc.
Cardiovascular · 149d
Cleared Mar 12, 1986
SONOLAYER S, SSH-60A/SDS-60A
K853115 · DXK
Toshiba Medical Systems
Cardiovascular · 231d
Cleared Mar 11, 1986
PATIENT MONITOR PB240
K853318 · DRT
Puritan Bennett Corp.
Cardiovascular · 216d
Cleared Mar 11, 1986
SIRECUST 341 AND 341R
K854881 · DRT
Siemens Medical Solutions USA, Inc.
Cardiovascular · 95d
Cleared Mar 11, 1986
MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD
K854917 · DTB
Intermedics, Inc.
Cardiovascular · 92d
Cleared Mar 11, 1986
MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD
K854918 · DTB
Intermedics, Inc.
Cardiovascular · 92d