Medical Device Manufacturer · US , Mchenry , IL

Electromedics, Inc. - FDA 510(k) Cleared Devices

41 submissions · 41 cleared · Since 1977

41

Total

41

Cleared

0

Denied

FDA 510(k) Regulatory Record - Electromedics, Inc. Cardiovascular ✕

17 devices

1-17 of 17

Cleared Dec 03, 1993

ELECTROMEDICS BLOOD HEAT EXCHANGER

Cardiovascular · 87d

Cleared Jul 01, 1993

EL2-SERIES BLOOD COLLECTION REERVOIR

Cardiovascular · 169d

Cleared Feb 19, 1993

ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR

Cardiovascular · 67d

Cleared Sep 03, 1992

AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR

Cardiovascular · 258d

Cleared May 16, 1991

MODIFIED PYROGEN TESTING

Cardiovascular · 91d

Cleared Dec 13, 1990

ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20

Cardiovascular · 177d

Cleared Nov 05, 1987

ELECTROMEDICS D1079E

Cardiovascular · 64d

Cleared May 21, 1985

ACR 2500 CARDIOTOMY RESERVOIR FILTER

Cardiovascular · 337d

Cleared Apr 29, 1985

POLYESTER CARDIOTOMY RESERVOIR, FILTERED & UNFILTE

Cardiovascular · 139d

Cleared Mar 22, 1984

MODEL TTPM TIME TEMP. PRESSURE MONITOR

Cardiovascular · 213d

Cleared Oct 20, 1983

CARDIOPLEGIA RECIRCULATION SYS-BL 705/A

Cardiovascular · 167d

Cleared May 25, 1983

HI FLEX D-700 MODULAR BUBBLE OXYGENA-

Cardiovascular · 85d

Cleared Jul 30, 1982

D645-BACTERIOLOGICAL GAS LINE FILTER

Cardiovascular · 14d

Cleared Jul 06, 1982

D6ZO DISPOSABLE HEAT EXCHANGER

Cardiovascular · 228d

Cleared Oct 23, 1981

SUCKER CARDIOTOMY RETURN, C.P. BYPASS

Cardiovascular · 56d

Cleared Oct 20, 1981

PHYSIOLOGICAL PRESSURE TRANSDUCER

Cardiovascular · 19d

Cleared Jan 13, 1981

Cardiovascular · 15d