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
10729–10752 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 14, 1995
XXL BALLON DILATATION CATHETER
K952063 · LIT
Boston Scientific Corp
Cardiovascular · 196d
Cleared Nov 13, 1995
SCIMED 6 FRENCH MICRO-MAX GUIDE CATHETER
K953909 · DQY
Scimed
Cardiovascular · 84d
Cleared Nov 09, 1995
HEARTHWATCH III(TM)
K945476 · DXH
Instromedix, Inc.
Cardiovascular · 366d
Cleared Nov 07, 1995
EDM
K951369 · DPW
Deltex Medical
Cardiovascular · 225d
Cleared Nov 07, 1995
MIKRO-TIP ANGIOGRAPHIC CATHETER
K952773 · DQO
Millar Instruments, Inc.
Cardiovascular · 144d
Cleared Nov 07, 1995
CORDIS WIZDOM STEERABLE GUIDEWIRE
K953760 · DQX
Cordis Corp.
Cardiovascular · 88d
Cleared Nov 07, 1995
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
K954085 · DTB
Medtronic Vascular
Cardiovascular · 71d
Cleared Nov 07, 1995
CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)
K954913 · DQX
Cardio Metrics, Inc.
Cardiovascular · 35d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MM
K950470 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MM
K950471 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MM
K950474 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM
K950477 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MM
K950478 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 06, 1995
DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MM
K950480 · DRX
Nikomed U.S.A., Inc.
Cardiovascular · 276d
Cleared Nov 02, 1995
WITT BIOMEDICAL SERIES IV
K950436 · MHX
Witt Biomedical Corporation
Cardiovascular · 273d
Cleared Nov 02, 1995
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
K951247 · DTZ
Baxter Healthcare Corp
Cardiovascular · 227d
Cleared Oct 31, 1995
CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS
K950003 · DXH
Instromedix, Inc.
Cardiovascular · 301d
Cleared Oct 31, 1995
ANALYST, MODEL DSP 300
K950760 · DQD
Heart Sounds, Inc.
Cardiovascular · 256d
Cleared Oct 31, 1995
BLOOD PRESSURE CUFF 1
K951039 · DXQ
Pedia Pals, Inc.
Cardiovascular · 239d
Cleared Oct 31, 1995
BLOOD PRESSURE CUFF 2
K951040 · DXQ
Pedia Pals, Inc.
Cardiovascular · 239d
Cleared Oct 31, 1995
BLOOD PRESSURE CUFF 3
K951041 · DXQ
Pedia Pals, Inc.
Cardiovascular · 239d
Cleared Oct 27, 1995
MINISCOPE MS-3
K954066 · DPS
Schiller America, Inc.
Cardiovascular · 58d
Cleared Oct 27, 1995
FEMOSTOP, FEMOSTOP PUMP
K954669 · DXC
Radi Medical Systems AB
Cardiovascular · 17d
Cleared Oct 26, 1995
A-V IMPULSE SYSTEM MODEL 6060
K951683 · JOW
Novamedix , Ltd.
Cardiovascular · 198d