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
13321–13344 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jan 17, 1989
E550 ELECTROCARDIOGRAPH
K883440 · DSI
Burdick Corp.
Cardiovascular · 155d
Cleared Jan 17, 1989
MEDTRONIC MODEL 4058 PACING LEAD
K883743 · DTB
Medtronic Vascular
Cardiovascular · 138d
Cleared Jan 17, 1989
INTRODUCER SAFETY SYRINGE
K884490 · DQX
Arrow Intl., Inc.
Cardiovascular · 83d
Cleared Jan 17, 1989
HOLTER 24-HOUR ECG PLAYBACK, MODEL 150
K884539 · DSI
Rmv Medical (Romavat, Inc.)
Cardiovascular · 81d
Cleared Jan 13, 1989
VENTRALITH I
K883750 · DXY
Bio Pace Technology, Inc.
Cardiovascular · 134d
Cleared Jan 13, 1989
PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT
K884421 · DXQ
Pymah Corp.
Cardiovascular · 85d
Cleared Jan 13, 1989
CORTRONIC SCR1000
K884911 · DSF
Cortronic Corp.
Cardiovascular · 49d
Cleared Jan 13, 1989
MAP DC-COUPLED ISOLATED PREAMPLIFIER MODEL #1001
K885252 · DRQ
Ep Technologies, Inc.
Cardiovascular · 30d
Cleared Jan 12, 1989
SENSOCOR(TM) DIASYS
K881771 · DXN
Sensormedix, Inc.
Cardiovascular · 261d
Cleared Jan 12, 1989
CATH LAB MONITORING CATHETER
K884065 · DQO
C.R. Bard, Inc.
Cardiovascular · 108d
Cleared Jan 12, 1989
TORAY VASCULAR PROSTHESIS
K884083 · DSY
Toray Industries (America), Inc.
Cardiovascular · 107d
Cleared Jan 12, 1989
NAMIC DUAL BACKCHECK VALVE
K884408 · DTL
North American Instrument Corp.
Cardiovascular · 85d
Cleared Jan 12, 1989
DOPCORD PPG
K884451 · JOM
Huntleigh Technology, Inc.
Cardiovascular · 80d
Cleared Jan 12, 1989
USCI ADJUSTABLE TIP GUIDE WIRE
K884647 · DQX
C.R. Bard, Inc.
Cardiovascular · 66d
Cleared Jan 12, 1989
FUKUDA DENSHI MODEL FX-1201
K884992 · DPS
Fukuda Denshi USA, Inc.
Cardiovascular · 42d
Cleared Jan 12, 1989
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K885101 · DSA
Medtronic Vascular
Cardiovascular · 31d
Cleared Jan 12, 1989
MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE
K885171 · DRO
Andover Medical, Inc.
Cardiovascular · 30d
Cleared Jan 11, 1989
TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER
K884375 · DQR
Argon Medical Corp.
Cardiovascular · 85d
Cleared Jan 10, 1989
ANGIOPUMP TUBING SET
K884310 · DWF
Olympus Corp.
Cardiovascular · 89d
Cleared Jan 10, 1989
MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER
K884331 · DTC
Medtronic Vascular
Cardiovascular · 88d
Cleared Jan 10, 1989
EDENTEC MODEL 4700 SCANNER
K884388 · DSF
Edentec Corp.
Cardiovascular · 84d
Cleared Jan 10, 1989
CLEAR SHOT ANGIOPLASTY BALLOON INFLATION DEVICE
K884481 · LIT
Mallinckroot, Inc.
Cardiovascular · 80d
Cleared Jan 05, 1989
ASK-300
K882977 · DQR
Medical Repackers Co.
Cardiovascular · 174d
Cleared Jan 05, 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · DSH
Del Mar Avionics
Cardiovascular · 83d