Medical Device Manufacturer · US , Mchenry , IL

Siemens Elema AB - FDA 510(k) Cleared Devices

63 submissions · 60 cleared · Since 1978

63

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - Siemens Elema AB Cardiovascular ✕

26 devices

1-12 of 26

Cleared Jan 23, 2002

KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E

Cardiovascular · 302d

Cleared Oct 05, 2000

CATHCOR DESKTOP

Cardiovascular · 83d

Cleared Oct 23, 1985

MANUAL VENTILATION ACCESSORY

Cardiovascular · 57d

Cleared Jun 26, 1985

CARDIOSTAT 3 RECORDER

Cardiovascular · 104d

Cleared Apr 11, 1985

CARDIOSTAT 1 ECG RECORDER

Cardiovascular · 149d

Cleared Dec 03, 1984

PULSE GENERATOR 689, 689B & 689L

Cardiovascular · 256d

Cleared Dec 03, 1984

PULSE GENERATOR 686, 686B 686L

Cardiovascular · 256d

Cleared Dec 03, 1984

PULSE GENERATOR 696, 696B & 696L

Cardiovascular · 256d

Cleared Nov 27, 1984

BIPOLAR ENDOCARDIAL LEAD 406L

Cardiovascular · 250d

Cleared Jul 06, 1984

PULSE GENERATOR 678L

Cardiovascular · 106d

Cleared Jun 26, 1984

PULSE GENERATOR 728, 728B & 728L

Cardiovascular · 96d

Cleared Jun 26, 1984

PULSE GENERATOR 718B & 718L

Cardiovascular · 96d