REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

CORE POUCH

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES

FDA 510(k)

FDA Class 2 ·Hematology

CANDIDA DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

CANDIDA IMMUNODIFFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

FDA 510(k)

FDA Class 2 ·Microbiology

DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST

FDA 510(k)

FDA Class 2 ·Microbiology

Interlude Rolled Tampons in Plastic Applicator

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Interlude 100% Cotton Tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

YO Home Sperm Test

FDA 510(k)

FDA Class 2 ·Hematology

Interlude and private label Unscented 3-piece compact applicator tampon

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

SONICWELD RX (RESORB-X)

FDA 510(k)

FDA Class 2 ·Dental

KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)

FDA 510(k)

FDA Class 2 ·Dental

PATIENT CONTOURED MESH-PEEK (PCM-P)

FDA 510(k)

FDA Class 2 ·Neurology

KLS MARTIN HAND PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

CENTRE-DRIVE DRILL-FREE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

PhoeniX

FDA 510(k)

FDA Class 2 ·Radiology

ARMAND ENDOSCOPE HOLDER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

KLS MARTIN DRILL-FREE MMF SCREW

FDA 510(k)

FDA Class 2 ·Dental