BIOPRO - INFINITY PLATE ANCHOR SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

RESOFIX BIOABSORBABLE EXPANSION BOLT

FDA 510(k)

FDA Class 2 ·Orthopedic

PUMA System

FDA 510(k)

FDA Class 2 ·Orthopedic

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·DTU-ONE ULTRASOUND SCANNER

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Aptima HCV Quant Dx Assay

DYNA IMPLANT DESIGN

FDA 510(k)

FDA Class 2 ·Dental

PICA WHOLE-BODY MRI SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

GO-PEN®

FDA 510(k)

FDA Class 2 ·General Hospital

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unistik® ShieldLock, Unistik VacuFlip

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unistik® Pro

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Unifine Pentips/ Unifine Pentips Plus

FDA 510(k)

FDA Class 2 ·General Hospital

Unifine SafeControl

FDA 510(k)

FDA Class 2 ·General Hospital

Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G

FDA 510(k)

FDA Class 2 ·General Hospital

Cantab Mobile

FDA 510(k)

FDA Class 2 ·Neurology

QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)

FDA 510(k)

FDA Class 2 ·Hematology