Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

MONITOR, AERATION, TEC-TEST

FDA 510(k)

FDA Class 2 ·General Hospital

ATI-PYMAH DISPOSABLE STEAM BIOLOGICAL TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

SELDINGER SINGLE WALL; STYLE I & II (FLASHBACK)

FDA 510(k)

FDA Class 2 ·Cardiovascular

BI-O.K. SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

SMART-WELL INCUBATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

FDA 510(k)

FDA Class 2 ·General Hospital

STERIGAGE INTEGRATOR TEST PACK FOR ETHYLENE OXIDE

FDA 510(k)

FDA Class 2 ·General Hospital

SPORVIEW

FDA 510(k)

FDA Class 2 ·General Hospital

ADVANSET

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOSURG DISPOSABLE SECONDARY TROCAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZTEST-STEAM

FDA 510(k)

FDA Class 2 ·General Hospital

STERITEC BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR

FDA 510(k)

FDA Class 2 ·General Hospital

VISITEC NEEDLE RANGE (CARDIOVASCULAR)

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE ANGIOGRAPHY NEEDLE, MODIFICATION

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATI DISP. BIOLOGICAL TEST PACK FOR ETHYLENE OXIDE

FDA 510(k)

FDA Class 2 ·General Hospital

ALIBI BIOLOGICAL INDICATOR, MODEL WS

FDA 510(k)

FDA Class 2 ·General Hospital

3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER

FDA 510(k)

FDA Class 2 ·General Hospital

PROSPORE

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292

FDA 510(k)

FDA Class 2 ·General Hospital