Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire JI Control Panel M420

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert MRSA NxG Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX CT/GC/TV 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert SA Nasal Complete Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert C. difficile/Epi Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert Respiratory Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Global Fever Panel External Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

FDA 510(k)

FDA Class 2 ·Radiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·SURGILENE

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PRONOVA ABSORABLE SUTURE, USP

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·PROLENE*POLYPROPYLENE SUTURE NONABSORBABLE SURG. S

Suture, Nonabsorbable, Synthetic, Polyethylene

FDA Pre-Market Approval

FDA Class 2 ·DEKLENE(TM)