HIGHPAK-12

FDA 510(k)

FDA Class 2 ·Cardiovascular

MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MENTOR OBTAPE TRANS-OBTURATOR TAPE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ISLAND BIOSURGICAL INC. BNS KIT #1 & #2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ArcSP Suprapubic Sling System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

DESARA MESH, DESARA BLUE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PUBOUURETHRAL SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO TRELEX MESH SURGICAL MESH

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MENTOR ARIS SUPRAPUBIC SURGICAL KIT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Dengue Nucleic Acid Amplification Assay (Naat)

FDA classification

FDA Class 2 ·Dengue Nucleic Acid Amplification Assay (Naat)

BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AMS COLLAGEN DERMAL MATRIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Plenity

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Epitomee

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Plenity

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology