Cystatin C

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

THD REVOLUTION

FDA 510(k)

FDA Class 2 ·Radiology

Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger

FDA 510(k)

FDA Class 2 ·Cardiovascular

MTS Omadacycline 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

ACE CALIBRATOR

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

MTS Imipenem-relebactam 0.002/4-32/4 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment

FDA 510(k)

FDA Class 2 ·Dental

Variolink Esthetic

FDA 510(k)

FDA Class 2 ·Dental

ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System

FDA 510(k)

FDA Class 2 ·Orthopedic

Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set

FDA 510(k)

FDA Class 2 ·Cardiovascular

SENTINEL PLASMAPROTEINS CAL 3X

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

PIEZOSURGERY PLUS

FDA 510(k)

FDA Class 2 ·Orthopedic

Physica LMC Knee System

FDA 510(k)

FDA Class 2 ·Orthopedic

SMR Reverse Liner

FDA 510(k)

FDA Class 2 ·Orthopedic

CRONO SUPER PID

FDA 510(k)

FDA Class 2 ·General Hospital

DRSplus

FDA 510(k)

FDA Class 2 ·Ophthalmic

Filbloc

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Galaxy UNYCO System

FDA 510(k)

FDA Class 2 ·Orthopedic

MicrUs

FDA 510(k)

FDA Class 2 ·Radiology

VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)

FDA 510(k)

FDA Class 2 ·Hematology