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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,027 results
10801–10824 of 18,027
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 12, 1995
CMS SYSTEM
K922528 · DQK
Micromedical Industries, Ltd.
Cardiovascular · 1079d
Cleared May 12, 1995
ECG MONITOR
K944262 · DRT
Fukuda Denshi USA, Inc.
Cardiovascular · 255d
Cleared May 10, 1995
VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIR
K941215 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 426d
Cleared May 10, 1995
MABIS BRAND AND MABIS CUSTOMERS PRIVATE LABEL BRAND
K942072 · DXN
Mabis Healthcare, Inc.
Cardiovascular · 376d
Cleared May 10, 1995
CARDIAC EVENT RECORDER (INSTANT MEMORY 2000)
K942586 · DXH
Telescan Medical Systems
Cardiovascular · 363d
Cleared May 10, 1995
HOLTER SSR DIGICORDER(TM)
K942653 · DSH
Del Mar Avionics
Cardiovascular · 341d
Cleared May 10, 1995
ELCAT D-PPG, PLETHYSMOGRAPH DEVICE
K944395 · JOM
Dermatology Assoc.
Cardiovascular · 243d
Cleared May 10, 1995
PROPAQ 200 MONITOR
K945071 · DRT
Protocol Systems, Inc.
Cardiovascular · 208d
Cleared May 10, 1995
1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED
K945384 · DSI
Siemens Medical Solutions USA, Inc.
Cardiovascular · 188d
Cleared May 10, 1995
MARINR SERIES EP DIAGNOSTI CATHETERS
K951347 · DRF
Medtronic Cardiorhythm
Cardiovascular · 71d
Cleared May 10, 1995
CVD BULLET INFUSION CATYHETER
K951502 · KRA
Cardiovascular Dynamics, Inc.
Cardiovascular · 43d
Cleared May 10, 1995
EMI MODEL FFF-IA
K952164 · DQK
New York Heart Instruments, Inc.
Cardiovascular · 7d
Cleared May 09, 1995
ARROW KINK RESISTANT FLEXI-CATH INTRA-AORTIC BALLOON
K945230 · DSP
Arrow Intl., Inc.
Cardiovascular · 195d
Cleared May 08, 1995
ATRAUMAX SURGICAL CLAMP
K950492 · DXC
Applied Medical Resources
Cardiovascular · 91d
Cleared May 04, 1995
ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER
K933417 · DRF
Echocath, Inc.
Cardiovascular · 660d
Cleared May 04, 1995
CVD BULLETT HI-FLO INFUSION CATHETER
K951503 · KRA
Cardiovascular Dynamics, Inc.
Cardiovascular · 37d
Cleared May 04, 1995
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · DRF
Boston Scientific Corp
Cardiovascular · 35d
Cleared May 03, 1995
PACETRAK
K943123 · DXH
Universal Medical, Inc.
Cardiovascular · 308d
Cleared May 03, 1995
HEARTRAK
K943124 · DXH
Universal Medical, Inc.
Cardiovascular · 308d
Cleared May 03, 1995
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
K950210 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 104d
Cleared Apr 28, 1995
CG-1000 PERSONAL ECG TRANSMITTER
K935909 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 505d
Cleared Apr 28, 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 239d
Cleared Apr 28, 1995
SIMON NITINOL FILTER
K944353 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 241d
Cleared Apr 28, 1995
PRECEDER GUIDEWIRE
K950352 · DQX
Boston Scientific Corp
Cardiovascular · 88d