IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308

FDA 510(k)

FDA Class 2 ·Anesthesiology

RIGID ENDOSCOPE

FDA 510(k)

FDA Class 2 ·Radiology

AMENDMENT ULTRASOUND SCANNER TYPE 1842/1846/1849

FDA 510(k)

FDA Class 2 ·Radiology

Theranos Herpes Simplex Virus-1 IgG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

EXERSYSTEM(TM) MMC 5000

FDA 510(k)

FDA Class 2 ·Anesthesiology

IDECAP DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ASTar BC G- Kit and ASTar Instrument

FDA 510(k)

FDA Class 2 ·Microbiology

DERMASSIST FLUID RESISTANT SURGICAL MASK (ORANGE) AND PROCEDURE MASK WITH TIE-ON AND WITH EARLOOPS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DERMASSIST FLUID RESISTANT SURGICAL MASK WITH WRAPAROUND VISOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+

FDA 510(k)

FDA Class 2 ·Radiology

ScandiDos Delta4 Phantom+

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Insight

FDA 510(k)

FDA Class 2 ·Radiology

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

FDA 510(k)

FDA Class 2 ·Radiology

DERMASSIST PROCEDURE MASK/SURGICAL MASKS (GREEN, BLUE, YELLOW, PINK, WHITE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DiviTum TKa

FDA 510(k)

FDA Class 2 ·Immunology

BREATHING FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

NuStat

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT

FDA 510(k)

FDA Class 2 ·Orthopedic

CPI MODEL 2215 & SEAMED MODEL 3400

FDA 510(k)

FDA Class 2 ·Cardiovascular