48 HOUR BIOLOGICAL INDICATORS SPORSTRIP

FDA 510(k)

FDA Class 2 ·General Hospital

STERRAD BI TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

STEIGER TUNNELING INSTRUMENT 285

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO STERRAD CYCLESURE BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER

FDA 510(k)

FDA Class 2 ·General Hospital

PROSPORE2 SELF-CONTAINED BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

EOGas 4 Endo-SteriTest RRBI

FDA 510(k)

FDA Class 2 ·General Hospital

Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)

FDA 510(k)

FDA Class 2 ·General Hospital

VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERIGAGE INTEGRATOR TEST PACK FOR STEAM STERILI.

FDA 510(k)

FDA Class 2 ·General Hospital

ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK

FDA 510(k)

FDA Class 2 ·General Hospital

STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR

FDA 510(k)

FDA Class 2 ·General Hospital

Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device

FDA 510(k)

FDA Class 2 ·General Hospital

SafeSept® Transseptal Guidewire (SS-140)

FDA 510(k)

FDA Class 2 ·Cardiovascular

LAPAROSCOPIC TROCAR

FDA 510(k)

FDA Class 2 ·Cardiovascular

STERIZONE VP4 Test Pack

FDA 510(k)

FDA Class 2 ·General Hospital

NAMIC ONE PART INTRODUCER NEEDLE

FDA 510(k)

FDA Class 2 ·Cardiovascular

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader

FDA 510(k)

FDA Class 2 ·General Hospital

DANA REUSABLE TEST PACK FOR STEAM STERILIZATION

FDA 510(k)

FDA Class 2 ·General Hospital

PROSPORE II

FDA 510(k)

FDA Class 2 ·General Hospital