Screw Sleeve Bone Fixation Device, Spine

FDA classification

FDA Class 2 ·Screw Sleeve Bone Fixation Device, Spine

Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

FDA classification

FDA Class 2 ·Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox

Assay, Proliferation, In Vitro, T Lymphocyte

FDA classification

FDA Class 2 ·Assay, Proliferation, In Vitro, T Lymphocyte

System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

FDA classification

FDA Class 2 ·System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home

Antimicrobial Blood Pressure Cuff

FDA classification

FDA Class 2 ·Antimicrobial Blood Pressure Cuff

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

FDA Pre-Market Approval

FDA Class 2 ·COBAS HCV TEST

Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

FDA classification

FDA Class 2 ·Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

FDA classification

FDA Class 2 ·Phenotypic Test Kit, Non-Susceptible/Elevated Mic Organisms, Cultured Isolates

Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

FDA classification

FDA Class 2 ·Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Assay For Detection Of Proteases In Chronic Wounds

FDA classification

FDA Class 2 ·Assay For Detection Of Proteases In Chronic Wounds

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

FDA classification

FDA Class 2 ·Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

Cardiovascular Machine Learning-Based Notification Software

FDA classification

FDA Class 2 ·Cardiovascular Machine Learning-Based Notification Software

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA classification

FDA Class 2 ·System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

Whole Slide Imaging System

FDA classification

FDA Class 2 ·Whole Slide Imaging System

Filler, Bone Void, Alterable Compound For Cranioplasty

FDA classification

FDA Class 2 ·Filler, Bone Void, Alterable Compound For Cranioplasty

Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

FDA classification

FDA Class 2 ·Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA classification

FDA Class 2 ·Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

FDA classification

FDA Class 2 ·Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use

Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

FDA classification

FDA Class 2 ·Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator