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
13849–13872 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 23, 1987
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · DSI
Oxford Medilog, Inc.
Cardiovascular · 70d
Cleared Nov 23, 1987
360D DC DEFIBRILLATOR
K874091 · LDD
Medac, Inc.
Cardiovascular · 47d
Cleared Nov 23, 1987
CIRCAMED MONITOR REMOTE START CONDUCTANCE METER
K874155 · KRC
Circadian, Inc.
Cardiovascular · 41d
Cleared Nov 23, 1987
SKIN PREP ANALYZER
K874327 · KRC
Marquette Electronics, Inc.
Cardiovascular · 33d
Cleared Nov 23, 1987
QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
K874394 · DXY
Intermedics, Inc.
Cardiovascular · 26d
Cleared Nov 20, 1987
TORAY ANTHRON ANGIOGRAPHIC CATHETERS
K872983 · DQR
Toray Industries (America), Inc.
Cardiovascular · 112d
Cleared Nov 16, 1987
ABCOM 1 CARDIAC OUTPUT MONITOR
K870857 · JOP
Applied Biometrics, Inc.
Cardiovascular · 258d
Cleared Nov 12, 1987
TUBING, POLYETHYLENE
K873597 · DXT
Coeur Laboratories, Inc.
Cardiovascular · 69d
Cleared Nov 06, 1987
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885 · DTB
Medtronic Vascular
Cardiovascular · 246d
Cleared Nov 06, 1987
GENESIS II
K871697 · DXK
Biosound, Inc.
Cardiovascular · 190d
Cleared Nov 06, 1987
SARNS CARDIOPLEGIA/VENT CATHETERS
K873212 · DWF
3M Health Care, Sarns
Cardiovascular · 84d
Cleared Nov 06, 1987
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · DTN
Johnson & Johnson Professionals, Inc.
Cardiovascular · 73d
Cleared Nov 06, 1987
BAIR HUGGER(TM) - PATIENT WARMING SYSTEM
K873745 · DWJ
Augustine Medical, Inc.
Cardiovascular · 51d
Cleared Nov 06, 1987
M300 MONITOR/CONTROLLER T500 TREADMILL
K873774 · DXJ
Burdick Corp.
Cardiovascular · 51d
Cleared Nov 06, 1987
PRESSURE BARRIER KIT CAT. NO. PBK-3
K873802 · DXS
American Omni Medical, Inc.
Cardiovascular · 49d
Cleared Nov 06, 1987
SARNS WARMER, PART #164975 AND #164980
K873813 · DWC
3M Health Care, Sarns
Cardiovascular · 49d
Cleared Nov 06, 1987
INTEGRATED MEMBRANE OXYGENATOR W/CARDIOTOMY FILTER
K873923 · DTZ
American Bentley
Cardiovascular · 42d
Cleared Nov 05, 1987
ELECTROMEDICS D1079E
K873561 · DTR
Electromedics, Inc.
Cardiovascular · 64d
Cleared Nov 05, 1987
MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE
K874117 · DYG
Medtronic Vascular
Cardiovascular · 27d
Cleared Nov 04, 1987
THE EXPERT MODELS RTS 2000 AND RTS 2000H
K862947 · DSI
Ocg Technology, Inc.
Cardiovascular · 456d
Cleared Nov 04, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K872766 · DXY
Telectronics, Inc.
Cardiovascular · 113d
Cleared Nov 04, 1987
PACESTART
K872778 · DRO
Pacific Rim Engineering & Mfg.
Cardiovascular · 113d
Cleared Nov 04, 1987
PROLOG MP PULSE GENERATORS 658K AND 658T
K872779 · DXY
Pacesetter Systems
Cardiovascular · 113d
Cleared Nov 04, 1987
MODEL 78576A PAPER CHART RECORDER
K872822 · DSF
Hewlett-Packard Co.
Cardiovascular · 110d