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
10657–10680 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 02, 1996
RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD
K955801 · DQX
Terumo Medical Corp.
Cardiovascular · 42d
Cleared Feb 01, 1996
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
K954714 · DTB
Pacesetter, Inc.
Cardiovascular · 122d
Cleared Feb 01, 1996
HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT
K954848 · MAL
Meadox Medicals, Div. Boston...
Cardiovascular · 101d
Cleared Jan 31, 1996
MARS DIGITAL BLOOD PRESSURE MONITOR
K945215 · DXN
Mars Metal Co., Ltd.
Cardiovascular · 463d
Cleared Jan 31, 1996
MAXI-TORQUE PLUS ANGIOGRAPHIC CATHETER
K955111 · DQO
Adam Spence Corp.
Cardiovascular · 84d
Cleared Jan 30, 1996
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
K943803 · DTQ
Janus Biomedical, Inc.
Cardiovascular · 544d
Cleared Jan 29, 1996
MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)
K952984 · DQO
Map Medical Equipment, Inc.
Cardiovascular · 215d
Cleared Jan 25, 1996
OMEGA CARES SYSTEM
K945068 · DQK
J-F Medical Systems Intl., Inc.
Cardiovascular · 468d
Cleared Jan 22, 1996
MEDTRONIC SHERPA GUIDING CATHETER
K955651 · DQY
Medtronics Interventional Vascular
Cardiovascular · 41d
Cleared Jan 19, 1996
STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
K950990 · DTQ
Stoeckert Instrumente
Cardiovascular · 322d
Cleared Jan 18, 1996
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM ROTABLATOR SYSTEM'S GUIDE WIRE LINE
K954604 · MCW
Heart Technology Mfg., Inc.
Cardiovascular · 106d
Cleared Jan 17, 1996
LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM
K952329 · DWJ
Progressive Dynamics, Inc.
Cardiovascular · 244d
Cleared Jan 16, 1996
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER
K951096 · DXH
Instromedix, Inc.
Cardiovascular · 315d
Cleared Jan 16, 1996
PACEART CARDIOVOICE
K952065 · DXH
Paceart, Inc.
Cardiovascular · 259d
Cleared Jan 16, 1996
SCIMED ANGIOGRAPHIC KITS
K953265 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 187d
Cleared Jan 16, 1996
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
K954501 · DTY
Medtronic Bio-Medicus, Inc.
Cardiovascular · 110d
Cleared Jan 11, 1996
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
K952659 · DSA
Tronomed, Inc.
Cardiovascular · 213d
Cleared Jan 11, 1996
PEDIATRIC QUIK-COMBO
K953204 · MKJ
Physio-Control Corp.
Cardiovascular · 189d
Cleared Jan 11, 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
K954431 · DSP
Boston Scientific Corp
Cardiovascular · 108d
Cleared Jan 11, 1996
SOFT VENOUS RESERVOIR
K955046 · DTN
Gish Biomedical, Inc.
Cardiovascular · 69d
Cleared Jan 04, 1996
HOLTER 6000
K950988 · DQK
Omega Medical Services, Inc.
Cardiovascular · 307d
Cleared Jan 04, 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE...
K951978 · LOS
Hewlett-Packard Co.
Cardiovascular · 252d
Cleared Jan 04, 1996
HEARTSTART 911
K954609 · MKJ
Laerdal Medical Corp.
Cardiovascular · 92d
Cleared Jan 02, 1996
MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
K954020 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 158d