Medical Device Manufacturer · US , Walker , MI

Suzuken Co., Ltd. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1981

Total

Cleared

Denied

Suzuken Co., Ltd. has 13 FDA 510(k) cleared cardiovascular devices. Based in Walker, US.

Historical record: 13 cleared submissions from 1981 to 2018.

Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Z&B Enterprises, Inc. as regulatory consultant.

Suzuken Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Suzuken Co., Ltd.

13 devices

1-12 of 13

Cleared Jun 01, 2018

Kenz Cardico1211

K172068 · DPS

Cardiovascular · 329d

Cleared Jan 06, 2011

KENZ CARDY302 MAX

K101024 · MWJ

Cardiovascular · 268d

Cleared Oct 13, 2009

DISPOSAL ECG ELECTRODES, MODEL EASYRODE

K092389 · DRX

Cardiovascular · 69d

Cleared Jan 08, 2001

KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS

K001896 · DPS

Cardiovascular · 201d

Cleared Jul 01, 1987

KENZ-CARDICO 1201

K870443 · LOS

Cardiovascular · 148d

Cleared Aug 06, 1986

KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH

Cardiovascular · 290d

Cleared Dec 15, 1982

ELECTROCARDIOGRAPH INTERPRETER

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 07, 2026

Suzuken Co., Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Suzuken Co., Ltd.

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