IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle

FDA 510(k)

FDA Class 2 ·General Hospital

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP (R)

Sharps Needle Destruction Device

FDA Pre-Market Approval

FDA Class 2 ·NEEDLE ZAP

EOS PMP, EOS PMP Integrated

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERFORMER HT/ HANG&GO HT BASIC

FDA 510(k)

FDA Class 2 ·General Hospital

SI-Restore Sacroiliac Joint Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

FDA 510(k)

FDA Class 2 ·Dental

Biomic Color Opaque

FDA 510(k)

FDA Class 2 ·Dental

AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control

FDA 510(k)

FDA Class 2 ·Ophthalmic

Dual Lumen Ecmo Cannula

FDA classification

FDA Class 2 ·Dual Lumen Ecmo Cannula

Single Lumen Ecmo Cannula

FDA classification

FDA Class 2 ·Single Lumen Ecmo Cannula

Exercise Equipment, Powered, Emg-Triggered

FDA classification

FDA Class 2 ·Exercise Equipment, Powered, Emg-Triggered

Endoscopic Morcellator Gastroenterology

FDA classification

FDA Class 2 ·Endoscopic Morcellator Gastroenterology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 GRAM NEGATIVE AST FOR AMIKACIN

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM, MODELS VITEK 2 AND VITEK 2 XL

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD (ESBL)

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·AMS GRAM-NEGITIVE ANTIMICROBIAL SUSCEPT. PANELS

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

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

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK SYSTEMS GENERAL SUSCEPTIBILITY CARD