Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·CHROMIC GUT STERILE ABSORBABLE SUTURES

Suture, Absorbable, Natural

FDA Pre-Market Approval

FDA Class 2 ·ABSORBABLE SURGICAL SUTURE, USP

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·AL-47 SOFT CONTACT LENS

Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

FDA classification

FDA Class 2 ·Alpha-D-Glucosidase (Gaa) Newborn Screening Test System

Autoantibodies, Glutamic Acid Decarboxylase (Gad)

FDA classification

FDA Class 2 ·Autoantibodies, Glutamic Acid Decarboxylase (Gad)

Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·DIASORIN ETI-HA-IGMK PLUS

Haptoglobin, Fitc, Antigen, Antiserum, Control

FDA classification

FDA Class 2 ·Haptoglobin, Fitc, Antigen, Antiserum, Control

Hepatitis A Test (Antibody And Igm Antibody)

FDA Pre-Market Approval

FDA Class 2 ·AB-HAVK, ETI-AB-HAVK, ETI-AB-HAVK PLUS

VivoSight Dx Topical OCT System

FDA 510(k)

FDA Class 2 ·Radiology

Arc Endocuff Glide AEG110 & AEG120

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VITROS Immunodiagnostic Products CEA Reagent Pack

FDA 510(k)

FDA Class 2 ·Immunology

CENTRAFIX EXTERNAL FIXATOR

FDA 510(k)

FDA Class 2 ·Orthopedic

Flexi-Seal PROTECT Fecal Management System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PICO SMOKERLYZER, MODEL EC-50

FDA 510(k)

FDA Class 2 ·Anesthesiology

EmbedMed

FDA 510(k)

FDA Class 2 ·Dental

Wearable breast pump

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DISPOS. I/A & IRRIGATION HANDPIECES

FDA 510(k)

FDA Class 2 ·Ophthalmic

MARQUETTE 1200 DEFIBRILLATION PADS

FDA 510(k)

FDA Class 2 ·Cardiovascular

MODIFICATION OF MLT R694 RUBY LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery