MEMOMETAL VARISATION, MODELS AV26-08, AV26-10, AV90-08 AND AV90-10

FDA 510(k)

FDA Class 2 ·Orthopedic

MEMOMETAL ANCHORAGE BONE PLATE SYSTEM, MODELS PLSS/PLSL, PLP10/PLP20/PLP30/PLP40/PLP50

FDA 510(k)

FDA Class 2 ·Orthopedic

HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG

FDA 510(k)

FDA Class 2 ·Cardiovascular

MEMOMETAL INTRA-MEDULLARY BONE FASTENER, MODELS SMART TOE / X-FUSE

FDA 510(k)

FDA Class 2 ·Orthopedic

HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE

FDA 510(k)

FDA Class 2 ·Cardiovascular

FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert® Xpress CoV-2 plus (XPRS-COV2-10)

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire COVID-19 Test 2

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima SARS-CoV-2 Assay

FDA 510(k)

FDA Class 2 ·Microbiology

cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa COVID-19 Direct

FDA 510(k)

FDA Class 2 ·Microbiology

HyperSnap Surgical System (HSS)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CLASSIC INTERMITTENT CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

FLEXICARE MEDICAL ENDOTRACHEAL TUBES

FDA 510(k)

FDA Class 2 ·Anesthesiology