COBAS INTEGRA BILIRUBIN DIRECT GEN.2

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDCOMP GEN III POWER INJECTABLE PORT

FDA 510(k)

FDA Class 2 ·General Hospital

AIA-PACK CTNI 2ND-GEN ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

TOTAL PROTEIN URINE/CSF GEN.3

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Nano 2nd Gen Pen Needle

FDA 510(k)

FDA Class 2 ·General Hospital

System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

FDA Pre-Market Approval

FDA Class 2 ·GEN-PROBE AMPLIFIED MYCOBACTERIUM TUBERCULOSIS DIRECT TEST(MTD TEST)

Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)

FDA 510(k)

FDA Class 2 ·Cardiovascular

XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICROL SYNTHETIC ABSORABLE SUTURE UNDYED

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910)

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE DYED

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL MESH

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRLY (POLYGLACTIN 910) SUTURE

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL MESH

Suture, Absorbable, Synthetic

FDA Pre-Market Approval

FDA Class 2 ·VICRYL (POLYGLACTIN 910) SUTURE