PICSI SPERM SELECTION DEVICE

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

Padlock Clip defect closure system, Padlock Pro-Select defect closure device

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FilmArray Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Tropical Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Susceptibility Test Cards, Antimicrobial

FDA Pre-Market Approval

FDA Class 2 ·VITEK 2 SYSTEM

Ultrasound, Infusion, System

FDA classification

FDA Class 2 ·Ultrasound, Infusion, System

Defect Measurement Tool

FDA classification

FDA Class 2 ·Defect Measurement Tool

Hematopoietic Cell Enrichment Kit

FDA classification

FDA Class 2 ·Hematopoietic Cell Enrichment Kit

Indicator, Physical/Chemical, Storage Temperature

FDA classification

FDA Class 2 ·Indicator, Physical/Chemical, Storage Temperature

Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

FDA classification

FDA Class 2 ·Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness

Internal Tissue Marker

FDA classification

FDA Class 2 ·Internal Tissue Marker

Embryo Image Assessment System, Assisted Reproduction

FDA classification

FDA Class 2 ·Embryo Image Assessment System, Assisted Reproduction

System, Immunomagnetic, Circulating Cancer Cell, Enumeration

FDA classification

FDA Class 2 ·System, Immunomagnetic, Circulating Cancer Cell, Enumeration

Shoulder Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Shoulder Arthroplasty Implantation System

Knee Arthroplasty Implantation System

FDA classification

FDA Class 2 ·Knee Arthroplasty Implantation System

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

FDA classification

FDA Class 2 ·Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Conformal Brachytherapy Source

FDA classification

FDA Class 2 ·Conformal Brachytherapy Source

Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm

FDA classification

FDA Class 2 ·Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm