WALLSTENT ENTERAL ENDOPROSTHESIS

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ZIDA Wearable Neuromodulation System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kenota 1 Total IgE; Kenota 1 (instrument)

FDA 510(k)

FDA Class 2 ·Immunology

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MODIFICATION TO AXYA MEDICAL, INC. BONE ANCHOR SYSTEM AND KIT (BAK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SUTURE WELDING SYSTEM AND KIT (SWK)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXYAFLEX POLYESTER SUTURE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ANKLE ARTHRODESIS PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

SPINE FRONTIER INDUS ACP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic