The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml.

FDA 510(k)

FDA Class 2 ·Microbiology

Contour Hand/Wrist (Q7000232)

FDA 510(k)

FDA Class 2 ·Radiology

Acu-sInQ Complete Endoscope Cleaning Aid System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4

FDA 510(k)

FDA Class 2 ·Radiology

INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)

FDA 510(k)

FDA Class 2 ·Orthopedic

TRU FLU

FDA 510(k)

FDA Class 2 ·Microbiology

TRIAD 88 NUCLEAR IMAGING SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

DIATEMP ELECTROSURGICAL PEN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CRYSTAL 5000 PHASES ARRAY TMJ COIL

FDA 510(k)

FDA Class 2 ·Radiology

Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

TRU Legionella

FDA 510(k)

FDA Class 2 ·Microbiology

Libra Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

VARELISA TPO ANTIBODIES, MODEL 12348/12396

FDA 510(k)

FDA Class 2 ·Immunology

FLUORESCENT T12 UVA TANNING LAMP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMRESCO FLOW PAC CHLORIDE REAGENT NO. 2256 & 2271

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

US ENDOSCOPY DISTAL ATTACHMENT CAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINI MAXLOCK EXTREME PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

SHOOCIN INTRODUCER KIT

FDA 510(k)

FDA Class 2 ·Cardiovascular