Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR GATIFLOXACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR NALIDIXIC ACID

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEX 2 GRAM NEGATIVE AST FOR AMPICILLIN/SULBACTAM

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)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM POSITIVE AST FOR HIGH-LEVEL STREPTOMYCIN

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·SECOND LOOK DIGITAL COMPUTER-AIDED DETECTION SYSTEM FOR MAMMOGRAPHY

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·PTCA DILATATION CATHETERS FOR VALOR AND VALOR XL PTCA

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK(R) 2 GRAM POSITIVE AST FOR TRIMETHOPRIM/SULFAMETHOXAZOLE

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·MEDTRONIC(R) PANTHER (TM) 40 COR..BALL. DIL. CATH.

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR QUINUPRISTIN/DALFOPRISTIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMOXICILLIN/CLAVULANIC ACID

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

MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery