Suture, Surgical, Absorbable, Polydioxanone

FDA Pre-Market Approval

FDA Class 2 ·PDS SUTURE (DYED)

Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill

FDA 510(k)

FDA Class 2 ·Orthopedic

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITIS C CHECK TESTING SERVICE

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C TEST SERVICE

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SYSTEM

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HEPATITS C CHECK TEST SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·HOME ACCESS HEPATITIS C CHECK TEST SERVICE

MTS Ceftobiprole 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

Stimulator, Nerve, For Restless Legs Syndrome

FDA classification

FDA Class 2 ·Stimulator, Nerve, For Restless Legs Syndrome

UltraFlo-R Push Button Blood Collection Set

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

E-CHECK (XE)

FDA 510(k)

FDA Class 2 ·Hematology

1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL

FDA 510(k)

FDA Class 2 ·Radiology

MODEL #510GE1500 LIVER ARRAY COIL

FDA 510(k)

FDA Class 2 ·Radiology

PARA 12 PLUS RETICS

FDA 510(k)

FDA Class 2 ·Hematology