STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

STAGO FACTOR V-DEFICIENT PLASMA

FDA 510(k)

FDA Class 2 ·Hematology

DRY LASER IMAGER, MODEL DRYPRO MODEL 793

FDA 510(k)

FDA Class 2 ·Radiology

20.1 MONOCHROME LCD MONITOR, RADIFORCE G20

FDA 510(k)

FDA Class 2 ·Radiology

DIRECT DIGITIZER, REGIUS MODEL 190

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION

FDA 510(k)

FDA Class 2 ·Radiology

Catheter, Urethrographic, Male

FDA classification

FDA Class 2 ·Catheter, Urethrographic, Male

Mesh, Surgical, For Stress Urinary Incontinence, Male

FDA classification

FDA Class 2 ·Mesh, Surgical, For Stress Urinary Incontinence, Male

AMYSYSTEMS PTS50CG 50 DEGREE WEIGHT SHIFT POWER TILT SYSTEM

FDA 510(k)

FDA Class 2 ·Physical Medicine

AMYSYSTEMS PTS50-50 DEGREE POWER TILT SYSTEM FOR MID-WHEEL OR FRONT-WHEEL DRIVE POWER WHEELCHAIRS.

FDA 510(k)

FDA Class 2 ·Physical Medicine

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

PURITAN FOAM TIP SWAB MODEL 2197

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN

FDA 510(k)

FDA Class 2 ·Immunology

Multi Modality Viewer

FDA 510(k)

FDA Class 2 ·Radiology

Alere i Instrument, Alere i Influenza A & B, Alere i Strep A

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

VENTREX ALLERGEN DISC

FDA 510(k)

FDA Class 2 ·Immunology

SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G

FDA 510(k)

FDA Class 2 ·Immunology

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology