Suture, Nonabsorbable, Synthetic, Polyamide

FDA Pre-Market Approval

FDA Class 2 ·ETHILON/NUROLON NYLON SUTURES

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension TPSA Flex reagent cartridge

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·Dimension Vista TPSA Flex reagent cartridge (K6451)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·BOIL N SOAK CONTACT LENS FLUID

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-AB-HAVK PLUS

Powered Microneedle Device

FDA classification

FDA Class 2 ·Powered Microneedle Device

Powered Insertion System For A Cochlear Implant Electrode Array

FDA classification

FDA Class 2 ·Powered Insertion System For A Cochlear Implant Electrode Array

Low Dead Space Piston Syringe

FDA classification

FDA Class 2 ·Low Dead Space Piston Syringe

Light, Lymphedema Reduction, Low Energy

FDA classification

FDA Class 2 ·Light, Lymphedema Reduction, Low Energy

Hemodialyzer, Re-Use, Low Flux

FDA classification

FDA Class 2 ·Hemodialyzer, Re-Use, Low Flux

Fat Reducing Low Level Laser

FDA classification

FDA Class 2 ·Fat Reducing Low Level Laser

Powered Exoskeleton

FDA classification

FDA Class 2 ·Powered Exoskeleton

Dc-Defibrillator, Low-Energy, (Including Paddles)

FDA classification

FDA Class 2 ·Dc-Defibrillator, Low-Energy, (Including Paddles)

Lipoprotein, Low-Density, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Lipoprotein, Low-Density, Antigen, Antiserum, Control

Generator, Low Voltage, Therapeutic X-Ray

FDA classification

FDA Class 2 ·Generator, Low Voltage, Therapeutic X-Ray

Collimator, Low Voltage, Therapeutic X-Ray

FDA classification

FDA Class 2 ·Collimator, Low Voltage, Therapeutic X-Ray

NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz

FDA 510(k)

FDA Class 2 ·Immunology