STAT TRACKS

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

restor3d Reverse Total Shoulder Arthroplasty System

FDA 510(k)

FDA Class 2 ·Orthopedic

3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRT TRANS-RECTAL TRANSDUCER

FDA 510(k)

FDA Class 2 ·Radiology

MEDCARE TRACHEOSTOMY CARE TRAY

FDA 510(k)

FDA Class 1 ·Unknown

MEDCARE REGIONAL ANETHESIA KIT

FDA 510(k)

FDA Class 2 ·Anesthesiology

SYNERGIST POWER PACK

FDA 510(k)

FDA Class 2 ·Ophthalmic

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

FDA 510(k)

FDA Class 2 ·Anesthesiology

Westmed Gas Sampling Cannula with O2 delivery

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTERA-SENSATION FAMILY

FDA 510(k)

FDA Class 2 ·Radiology

QLAB QUANTIFICATION

FDA 510(k)

FDA Class 2 ·Radiology

ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL

FDA 510(k)

FDA Unclassified ·Unknown

VISTA ANTIGEN SALMONELLA O GROUP B

FDA 510(k)

FDA Class 2 ·Microbiology

ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5

FDA 510(k)

FDA Class 2 ·Radiology

LUMAX CYSTOMETRY ADMINISTRATION TUBE SET

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

THE FINGER GUARD

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER

FDA 510(k)

FDA Class 2 ·Cardiovascular

AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

IU22 ULTRASOUND SYSTEM AND TRANSDUCERS

FDA 510(k)

FDA Class 2 ·Radiology

PHILIPS IU22 ULTRASOUND SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology