POWERTREK INSTRUMENTS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)

FDA 510(k)

FDA Class 2 ·Microbiology

TOSAMA Reusable Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

inspired™ VHB20 Heated Humidifier

FDA 510(k)

FDA Class 2 ·Anesthesiology

EASYDRILL AUTOSTOP CRANIAL PERFORATOR

FDA 510(k)

FDA Class 2 ·Neurology

AGACHAMBER SPACER

FDA 510(k)

FDA Class 2 ·Anesthesiology

BLOM-SINGER LOW PRESSURE VOICE PROSTHES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

LOW PRESSURE BLOM-SINGER VOICE PROSTHES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARDIAC OUTPUT COMPUTER, MODEL COM-3

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPO2.COM OXIMETRY SENSORS, MULTIPLE MODELS

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE

FDA 510(k)

FDA Class 2 ·Anesthesiology

ProSeal™ Closed System drug Transfer Device (CSTD)

FDA 510(k)

FDA Class 2 ·General Hospital

TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM

FDA 510(k)

FDA Class 2 ·Orthopedic

MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311

FDA 510(k)

FDA Class 2 ·General Hospital

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2

FDA 510(k)

FDA Class 2 ·Cardiovascular

BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat