MTS Omadacycline 0.002-32 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

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

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

Screw Sleeve Bone Fixation Device, Spine

FDA classification

FDA Class 2 ·Screw Sleeve Bone Fixation Device, Spine

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FDA classification

FDA Class 2 ·Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Instruments Designed For Press-Fit Osteochondral Implants

FDA classification

FDA Class 2 ·Instruments Designed For Press-Fit Osteochondral Implants

Hearing Aid, Air Conduction, Transcutaneous System

FDA classification

FDA Class 2 ·Hearing Aid, Air Conduction, Transcutaneous System

Syringe, Piston, Reprocessed

FDA classification

FDA Class 2 ·Syringe, Piston, Reprocessed