IFA SENSIBAC CINOXACIN

FDA 510(k)

FDA Class 2 ·Microbiology

MERCURY DENTAL

FDA 510(k)

FDA Class 2 ·Dental

IFA SENSIBAC KANAMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

IFA SENSIBAC PENICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

IFA SENSIBAC STREPTOMYCIN

FDA 510(k)

FDA Class 2 ·Microbiology

ARiX RAD Radiographic System

FDA 510(k)

FDA Class 2 ·Radiology

IFA SENSIBAC CEFACLOR

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST

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

FDA Pre-Market Approval

FDA Class 2 ·AMPLICOR HCV/COBAS AMPLICOR HCV TEST

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT IMX(R) HAVAB(R)-M

V-PRO® 1 Plus and V-PRO® maX Low Temperature

FDA 510(k)

FDA Class 2 ·General Hospital

Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory

FDA 510(k)

FDA Class 2 ·Radiology

RENASYS; EZ MAX Negative Pressure Wound Therapy; Foam NPWT Wound Dressing Kits with Soft Port; Gauze NPWT Wound Dressing Kits with Soft Port; EZ PLUS/EZ MAX Canisters

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Genotype II Amplification Reagent Kit / HCV Genotype II Control Kit

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

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time HCV Amplification Reagent Kit /HCV Control Kit /HCV Calibrator Kit

Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit.

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS TAQMAN HCV TEST V2.0 FOR USE WITH THE HIGH PURE SYSTEM

V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System

FDA 510(k)

FDA Class 2 ·General Hospital

HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)

FDA 510(k)

FDA Class 2 ·General Hospital

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)

FDA 510(k)

FDA Class 2 ·Radiology