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
10921–10944 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 15, 1995
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
K946188 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 146d
Cleared May 15, 1995
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · DXE
Applied Medical Resources
Cardiovascular · 95d
Cleared May 15, 1995
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
K950751 · DXY
Medtronic Vascular
Cardiovascular · 87d
Cleared May 15, 1995
ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS
K950752 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 87d
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