VAN-TEC BLADDER EVACUATOR

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

DEPUY ATTUNE TOTAL KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

CXI SUPPORT CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

URISYS 2400 URINE TEST STRIP

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ANATOMIC MODULAR KNEE (AMK) SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Zimmer Persona Personalized Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF

FDA 510(k)

FDA Class 2 ·Orthopedic

Arcos One-piece Femoral Revision System

FDA 510(k)

FDA Class 2 ·Orthopedic

Electrode, Ion Based, Enzymatic, Creatinine

FDA classification

FDA Class 2 ·Electrode, Ion Based, Enzymatic, Creatinine

Electrode, Ion Specific, Urea Nitrogen

FDA classification

FDA Class 2 ·Electrode, Ion Specific, Urea Nitrogen

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

BD Veritor System for SARS-CoV-2

FDA 510(k)

FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

Teal Wand

FDA 510(k)

FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology