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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF ICD, MRI ICD, S DR ICD, S VR ICD, XT DR ICD, XT VR ICD - Visia AF MRI DFI ICD, AF MRI VR ICD, AF VR ICD

Advocate Blood Pressure Monitor, Wrist, Model SPBP-02, Bilingual

FDA UDI

DIABETIC SUPPLY OF SUNCOAST, INC.·00894046001516·Advocate Blood Pressure Monitor, Wrist, Model S...

DIGORA

FDA 510(k)

FDA Class 2 ·Radiology

DENTOCULT SM-STRIP MUTANS

FDA 510(k)

FDA Class 1 ·Microbiology

DELFIA NEONATAL 17A-OH-PROGESTERONE KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

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

CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

SNAPSHOT

FDA 510(k)

FDA Class 2 ·Dental

Bindex BI-100

FDA 510(k)

FDA Class 2 ·Radiology

BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS

FDA 510(k)

FDA Class 2 ·Dental

OP300

FDA 510(k)

FDA Class 2 ·Radiology

MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

FDA 510(k)

FDA Class 1 ·Clinical Chemistry