VERIFY Assert Self-Contained Biological Indicator

FDA 510(k)

FDA Class 2 ·General Hospital

Celerity Incubator

FDA 510(k)

FDA Class 2 ·General Hospital

HEARTPORT NEEDLE TROCAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

DISPOSABLE ANGIOGRAPHY NEEDLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

KENWOOD BIOLOGICAL STEOILIZ. INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

STERRAD CYCLESURE BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

FDA 510(k)

FDA Class 2 ·General Hospital

DILUTION KIT, THERMAL, COLD PAC

FDA 510(k)

FDA Class 2 ·Cardiovascular

SafeSept Transseptal Guidewire

FDA 510(k)

FDA Class 2 ·Cardiovascular

ATI(R) DISP BIOLOGICAL-PLUS TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

DISPOSABLE STEAM BIOLOGICAL TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS

FDA 510(k)

FDA Class 2 ·General Hospital

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

FDA 510(k)

FDA Class 2 ·General Hospital

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

FDA 510(k)

FDA Class 2 ·General Hospital

SELDINGER PERCUTANEOUS 2 PC NEEDLES

FDA 510(k)

FDA Class 2 ·Cardiovascular

Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)

FDA 510(k)

FDA Class 2 ·General Hospital

BI-O.K. STEAM TEST-PAK

FDA 510(k)

FDA Class 2 ·General Hospital

TSN Transseptal Needle

FDA 510(k)

FDA Class 2 ·Cardiovascular

BCR-30-min BI™ and RBIP-ST30™ Readout Accessory

FDA 510(k)

FDA Class 2 ·General Hospital

STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital