PREMIUM - SHELTA Prosthetic Components

FDA 510(k)

FDA Class 2 ·Dental

DRF 4343

FDA 510(k)

FDA Class 2 ·Radiology

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ReadeR, VieweR, QuickScan PSP

FDA 510(k)

FDA Class 2 ·Dental

Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

MINIMA S System

FDA 510(k)

FDA Class 2 ·Orthopedic

ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

FDA 510(k)

FDA Class 2 ·Ophthalmic

PREMIUM, SHELTA Implant Systems

FDA 510(k)

FDA Class 2 ·Dental

DISPOSABLE ADHESIVE SURFACE ELECTRODE

FDA 510(k)

FDA Class 2 ·Neurology

MRopen EVO

FDA 510(k)

FDA Class 2 ·Radiology

SENTINEL LITHIUM ASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE

FDA 510(k)

FDA Class 2 ·Dental

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button

FDA 510(k)

FDA Class 2 ·Orthopedic

AMF TT Cones

FDA 510(k)

FDA Class 2 ·Orthopedic

DentCare Aligners

FDA 510(k)

FDA Class 2 ·Dental

ORION

FDA 510(k)

FDA Class 2 ·Ophthalmic

DEKA SYNCHRO FT

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Latitud Hip Replacement System

FDA 510(k)

FDA Class 2 ·Orthopedic

Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL

FDA 510(k)

FDA Class 2 ·Microbiology

NuEra Tight RF Model OptiStream

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery