FILMARRAY GI Panel

FDA registration

BioFire Diagnostics, LLC·1 product·🇺🇸 United States

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

FDA classification

FDA Class 2 ·Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System

BEAR MEDIC CORPORATION

FDA registration

BEAR MEDIC CORPORATION·1 product·🇯🇵 Japan

KOBAYASHI SHOJI K.K.

FDA registration

KOBAYASHI SHOJI K.K.·1 product·🇯🇵 Japan

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·1 product·🇺🇸 United States

Synergy Health AST, SRL

FDA registration

Synergy Health AST, SRL·1 product·🇨🇷 Costa Rica

Primary Set

FDA registration

ICU Medical Costa Rica Ltd.·1 product·🇨🇷 Costa Rica

AROS SURGICAL INSTRUMENTS CORPORATION

FDA registration

AROS SURGICAL INSTRUMENTS CORPORATION·1 product·🇺🇸 United States

Primary Set

FDA registration

ICU MEDICAL, INC.·1 product·🇺🇸 United States

MEM Aligner

FDA registration

MEM DENTAL TECHNOLOGY CO LTD·1 product·🇹🇼 Taiwan

IQ - UIP

FDA registration

4DMEDICAL LIMITED·1 product·🇦🇺 Australia

NYLON THREADED NEEDLE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hospira Primary Sets

FDA 510(k)

FDA Class 2 ·General Hospital

Suture, Nonabsorbable, Synthetic, Polyamide

FDA classification

FDA Class 2 ·Suture, Nonabsorbable, Synthetic, Polyamide

Set, Administration, Intravascular

FDA classification

FDA Class 2 ·Set, Administration, Intravascular