Medical Device Manufacturer · US , Mccordsville , IN

Caradyne, Ltd. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1999

Recent clearances: GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM, OXICHECK, CRITERION 60 OR PM 60

View 5 510(k) Devices ↓

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - Caradyne, Ltd. Anesthesiology ✕

5 devices

1-5 of 5

Cleared Jun 30, 2004

GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

Anesthesiology · 89d

Cleared Mar 28, 2003

Anesthesiology · 156d

Cleared Jun 22, 2000

CRITERION 60 OR PM 60

Anesthesiology · 90d

Cleared Jan 06, 2000

CRITERION 40 OR PM 40

Anesthesiology · 198d

Cleared Mar 09, 1999

WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW...

Anesthesiology · 252d