BIODEX ACT-O-KIT TSH-RIA-

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Hem-o-lok® Ligating Clips

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

O.22/UM FILTERSET W/FLASHBACK

FDA 510(k)

FDA Class 2 ·General Hospital

LIF-O-GEN #3000 OXYGEN CONCENTRATOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

SAS SALMONELLA O FACTOR 14 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

TRACER O-T-W MAPPING DEVICE

FDA 510(k)

FDA Class 2 ·Cardiovascular

GCE Zen-O Portable Oxygen Concentrator

FDA 510(k)

FDA Class 2 ·Anesthesiology

LEW MDI O-BALL COLLARED IMPLANT,

FDA 510(k)

FDA Class 2 ·Dental

SAPPHIRE O/E ORAL EXAMINATION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

SAS SALMONELLA O POLY B ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SOLUTION ADMINISTRATION SET (W/O NEEDLE)

FDA 510(k)

FDA Class 2 ·General Hospital

ARTHROSCOPIC LUMBAR MECHANICAL AND LASER DISCECTOM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PIASMA SAFE

FDA 510(k)

FDA Class 2 ·Hematology

SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·VALOR AND VALOR XL PTCA DILATATION CATHETERS

MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology