Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval

FDA Class 3 ·SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation System

S.A.F. ACETABULAR CUP WITH POROUS COATING

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

FMS MODEL 110

FDA 510(k)

FDA Class 3 ·Obstetrics/Gynecology

STERILE POLYHESIVE PBS DRESSING

FDA 510(k)

FDA Class 3 ·Unknown

KM-3 ACETABULAR COMPONENT

FDA 510(k)

FDA Class 3 ·Orthopedic

ATH METAL:UHMWPE TOTAL HIP SYSTEM

FDA 510(k)

FDA Class 3 ·Orthopedic

POROUS-COATED TITANIUM ACETABULAR CUP

FDA 510(k)

FDA Class 3 ·Orthopedic

Absorbable Collagen Hemostatic Agent With Thrombin

FDA classification

FDA Class 3 ·Absorbable Collagen Hemostatic Agent With Thrombin

Immunohistochemistry Assay, Antibody, Met

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Met

Immunohistochemistry Assay, Antibody, Claudin 18

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Claudin 18

Immunohistochemistry Assay, Antibody, Folr1

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Folr1

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

Diagnostic Low Electric Field

FDA classification

FDA Class 3 ·Diagnostic Low Electric Field

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

Continuous Glucose Monitor, Implanted, Adjunctive Use

FDA classification

FDA Class 3 ·Continuous Glucose Monitor, Implanted, Adjunctive Use

Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

FDA classification

FDA Class 3 ·Mycobacterium Tuberculosis, Cell Mediated Immune Response, Enzyme-Linked Immunospot Test

Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

FDA classification

FDA Class 3 ·Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay