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

NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

RespiraSense

FDA 510(k)

FDA Class 2 ·Anesthesiology

HealthBeacon HB2 Sharps Bin

FDA 510(k)

FDA Class 2 ·General Hospital

Simple 2 Test

FDA 510(k)

FDA Class 2 ·Microbiology

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

FDA 510(k)

FDA Class 2 ·Ophthalmic

CARDIOCAP CCK-104 KEYBOARD & CCP-104 GRAPHICS PRIN

FDA 510(k)

FDA Class 2 ·Anesthesiology

SNAPSHOT

FDA 510(k)

FDA Class 2 ·Dental

STREAMER POLYMER GUIDEWIRE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Vitalograph Model 6600 Compact

FDA 510(k)

FDA Class 2 ·Anesthesiology

OLYMPUS CK-MB REAGENT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bindex BI-100

FDA 510(k)

FDA Class 2 ·Radiology

AMYLASE (ETHYLIDENE PNGPG7) KIT

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

FDA 510(k)

FDA Class 2 ·Dental