Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia/Pneumoniaplus Control

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire JI Control Panel M420

FDA 510(k)

FDA Class 2 ·Microbiology

SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert MRSA NxG Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX CT/GC/TV 20-Day QC Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert SA Nasal Complete Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert C. difficile/Epi Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Cepheid Xpert Respiratory Control Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Global Fever Panel External Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Belun Ring BLR-200 (BLR-200)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Skypro, SP02 Mask (3)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HORIZON 2000 TRANSCUTANEOUS GAS #26X-OPT-275

FDA 510(k)

FDA Class 2 ·Anesthesiology

TCM400

FDA 510(k)

FDA Class 2 ·Anesthesiology

HTS EXTREMITY COIL, HTS SURFACE COIL

FDA 510(k)

FDA Class 2 ·Radiology

BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Micro Electrode (Brass with gold plated shaft); Single Use Micro Electrode (Stainless Steel shaft)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Single Use Arthroscopic Electrode (with Pencil)

FDA 510(k)

FDA Class 2 ·Orthopedic

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry