Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT

FDA 510(k)

FDA Class 2 ·Hematology

SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL

FDA 510(k)

FDA Class 2 ·Dental

DIASTAT ENA SINGLE WELL SCREEN KIT

FDA 510(k)

FDA Class 2 ·Immunology

Unipro (K-UNIPRO-US)

FDA 510(k)

FDA Class 2 ·Neurology

Total Bilirubin

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MEDICHEART, MODEL RELEASE 1

FDA 510(k)

FDA Class 2 ·Radiology

DIASTAT ANTI-MPO (PANCA) KIT

FDA 510(k)

FDA Class 2 ·Immunology

ORTHO VLC; ORTHO VLC CAPSULE

FDA 510(k)

FDA Class 2 ·Dental

ALBUMIN IN URINE

FDA 510(k)

FDA Class 2 ·Immunology

MIE FALCON, DATEX ENGSTROM FLEXIMA II

FDA 510(k)

FDA Class 2 ·Anesthesiology

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30

FDA 510(k)

FDA Class 2 ·Microbiology

HUNTER SCIENTIFIC INJECTION PIPETTES

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Elekta Unity

FDA 510(k)

FDA Class 2 ·Radiology

DCM (PW-DCM)

FDA 510(k)

FDA Class 2 ·Neurology

Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling

FDA 510(k)

FDA Class 2 ·Orthopedic

Tempus Pro Patient Monitor

FDA 510(k)

FDA Class 2 ·Cardiovascular

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

FDA 510(k)

FDA Class 2 ·Hematology

Disposable Intraoperative Probe (DIOP8)

FDA 510(k)

FDA Class 2 ·Radiology

AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100

FDA 510(k)

FDA Class 2 ·Clinical Chemistry