Medical Device Manufacturer · US , Rochester , NY

Getinge USA, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2003

Recent clearances: SPOR-TEST PA BIOLOGICAL INDICATOR KIT, BIOSIGN STEAM-24 BIOLOGICAL INDICATOR, BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

View 4 510(k) Devices ↓

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Getinge USA, Inc. General Hospital ✕

4 devices

1-4 of 4

Cleared Apr 07, 2005

SPOR-TEST PA BIOLOGICAL INDICATOR KIT

General Hospital · 23d

Cleared Oct 01, 2003

BIOSIGN STEAM-24 BIOLOGICAL INDICATOR

General Hospital · 28d

Cleared Jul 29, 2003

BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

General Hospital · 63d

Cleared May 12, 2003

MODEL 833HC VACUUM/GRAVITY STEAM STERILIZER

General Hospital · 21d