Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA Pre-Market Approval

FDA Class 2 ·PRO OSTEON IMPLANT 500 HYDROXYAPATITE BONE VOID FILLER

Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

FDA 510(k)

FDA Class 2 ·Neurology

Lithotriptor, Extracorporeal Shock-Wave, Urological

FDA Pre-Market Approval

FDA Class 2 ·DORNIER LITHOTRIPTER AND DORNIER LITHOTRIPTER TRANSPORTABLE

ANSPACH SUTURE ANCHOR

FDA 510(k)

FDA Class 2 ·Orthopedic

ANSPACH MICROMAX SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

INVADER FACTOR II

FDA 510(k)

FDA Class 2 ·Hematology

cobas Factor II and Factor V Test

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

FACTOR II (PROTHROMBIN) G20210A KIT

FDA 510(k)

FDA Class 2 ·Hematology

Xpert® FII & FV

FDA 510(k)

FDA Class 2 ·Hematology

Antithrombin Iii Quantitation

FDA classification

FDA Class 2 ·Antithrombin Iii Quantitation

Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

FDA classification

FDA Class 2 ·Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody

System, Dialysate Delivery, Sealed

FDA classification

FDA Class 2 ·System, Dialysate Delivery, Sealed

Antigen, Antiserum, Control, Antithrombin Iii

FDA classification

FDA Class 2 ·Antigen, Antiserum, Control, Antithrombin Iii

Antithrombin Iii, Two Stage Clotting Time Assay

FDA classification

FDA Class 2 ·Antithrombin Iii, Two Stage Clotting Time Assay

Assay, Genotyping, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT REALTIME HCV GENOTYPE II, ABBOTT REALTIME HCV GENOTYPE II CONTROL KIT, URACIL-N-GLYCOSYLASE (UNG)

Droplet Digital Pcr System

FDA classification

FDA Class 2 ·Droplet Digital Pcr System

21-Hydroxylase Antibody (21-Ohab)

FDA classification

FDA Class 2 ·21-Hydroxylase Antibody (21-Ohab)

Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

FDA classification

FDA Class 2 ·Test, Factor Ii G20210a Mutations, Genomic Dna Pcr

Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment

FDA classification

FDA Class 2 ·Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment