Steriking® LT-Blueline Pouches with Tyvek®

FDA 510(k)

FDA Class 2 ·General Hospital

PLANMECA PROMAX 3D

FDA 510(k)

FDA Class 2 ·Dental

Planmed Clarity

FDA 510(k)

FDA Class 2 ·Radiology

Steriking Packaging for Medical Devices

FDA 510(k)

FDA Class 2 ·General Hospital

Steriking® Pouch for Robotic Instruments

FDA 510(k)

FDA Class 2 ·General Hospital

MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO

FDA 510(k)

FDA Class 2 ·Anesthesiology

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System

FDA 510(k)

FDA Class 2 ·Neurology

CARESCAPE B650

FDA 510(k)

FDA Class 2 ·Cardiovascular

PLANMECA PROMAX 3D MID

FDA 510(k)

FDA Class 2 ·Dental

CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01)

FDA 510(k)

FDA Class 2 ·Cardiovascular

Galectin-3 In Vitro Diagnostic Assay

FDA classification

FDA Class 2 ·Galectin-3 In Vitro Diagnostic Assay

Cervical Intraepithelial Neoplasia (Cin) Test System

FDA classification

FDA Class 2 ·Cervical Intraepithelial Neoplasia (Cin) Test System

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM)

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

Monitor, Uterine Contraction, External (For Use In Clinic)

FDA Pre-Market Approval

FDA Class 2 ·GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS.

INFUSION SET

FDA 510(k)

FDA Class 2 ·General Hospital

FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbable polyamide surgical Sutures, MERICRON XL - Non Absorbable Polyester Surgical Suture, FILAPROP - Non Absorbable Polypropylene surgical Suture

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Kentrospine PSS Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

FDA 510(k)

FDA Class 2 ·Ophthalmic