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
11833–11856 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 16, 1992
CBIS CATHETER PULL-BACK DEVICE
K921879 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jul 14, 1992
ACCUTRACKER DX
K913844 · DXN
Suntech Medical Instruments, Inc.
Cardiovascular · 321d
Cleared Jul 09, 1992
CARDIO-CARD ECG MANAGEMENT SYSTEM
K920020 · DPS
Nasiff Assoc., Inc.
Cardiovascular · 189d
Cleared Jul 08, 1992
SARNS 8000 MODULAR PERFUSION SYSTEM
K915183 · DTQ
3M Health Care, Sarns
Cardiovascular · 233d
Cleared Jul 07, 1992
SMI MODEL 210 AMBULATORY ECG MONITORING SYSTEM
K920294 · LOS
Stuart Medical, Inc.
Cardiovascular · 167d
Cleared Jul 07, 1992
EMD TRANSTELEPHONIC RECORDER AND RECEIVER # 1200
K920765 · DXH
Electronic Monitoring Devices, Inc.
Cardiovascular · 139d
Cleared Jul 06, 1992
LIFE-TEL L.B.E.(LIFE-PAK 5/10 BATTERY ELIMINATOR)
K920990 · LDD
Raco Products Co.
Cardiovascular · 126d
Cleared Jul 06, 1992
ECG MODULATOR
K922412 · DXH
Maguire Ent., Inc.
Cardiovascular · 46d
Cleared Jul 01, 1992
MEGACART
K915225 · LOS
Siemens Burdick, Inc.
Cardiovascular · 224d
Cleared Jun 29, 1992
GEL-TAC
K915328 · DRO
Katecho, Inc.
Cardiovascular · 216d
Cleared Jun 29, 1992
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER
K915351 · DQO
Medtronics Interventional Vascular
Cardiovascular · 216d
Cleared Jun 23, 1992
TYPE 9050/NEO
K912183 · DPS
S & W Medico Teknik
Cardiovascular · 404d
Cleared Jun 22, 1992
JOBST EXTREMITY PUMP SYSTEM 7500
K921562 · JOW
Jobst Institute, Inc.
Cardiovascular · 82d
Cleared Jun 18, 1992
ARROW QUADPOLAR MAPPING/PACING CATHETER
K911065 · DRF
Arrow Intl., Inc.
Cardiovascular · 463d
Cleared Jun 18, 1992
BAIR HUGGER CUB BLANKET- SHORT MODEL 536
K920432 · DWJ
Augustine Medical, Inc.
Cardiovascular · 136d
Cleared Jun 17, 1992
SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO (PTA) BAL
K921943 · LIT
Schneider Intl., Ltd.
Cardiovascular · 54d
Cleared Jun 11, 1992
MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE)
K922172 · LDD
Cardiotronics, Inc.
Cardiovascular · 34d
Cleared Jun 11, 1992
MODEL # 830 ST ADULT STIMULATION PADS (STERILE)
K922173 · LDD
Cardiotronics, Inc.
Cardiovascular · 34d
Cleared Jun 11, 1992
MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE
K922227 · LDD
Cardiotronics, Inc.
Cardiovascular · 30d
Cleared Jun 10, 1992
MORSE HEMOSTATIC CATHETER INTRODUCER SET
K915078 · DYB
North American Instrument Corp.
Cardiovascular · 215d
Cleared Jun 10, 1992
SPECTRA ECG
K915658 · LOS
Advanced Medical Products, Inc.
Cardiovascular · 175d
Cleared Jun 09, 1992
SCIMED(R) CONTROLWIRE(TM) GUIDE WIRE
K914194 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 265d
Cleared Jun 09, 1992
.10' HI-TORQUE FLOPPY, INTER. & STAND. GUIDE WIRE
K915723 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 172d
Cleared Jun 05, 1992
R-GROUP INTL. ONE WALL PUNCTURE NEEDLE
K913267 · DRC
R-Group Intl.
Cardiovascular · 318d