KöR

FDA UDI

EVOLVE DENTAL TECHNOLOGIES, INC.·00850362007120·Dental retractor and suction tip.

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape

FDA UDI

JK-Products GmbH·EJKP100003334A0·

KöR

FDA UDI

EVOLVE DENTAL TECHNOLOGIES, INC.·00850362007113·Dental cheek retractor and suction tip.

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape -PF

FDA UDI

JK-Products GmbH·EJKP100003356A0·

Ergoline/ SUNRISE 480 Turbo Power + Vibra Shape

FDA UDI

JK-Products GmbH·EJKP100003333A0·

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Natural Eyes HydraWear™ XW Multifocal

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ROCHE ONLINE TDM PHENYTOIN

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Phosphate Buffered Saline (PBS) 1X w/o Ca & Mg, Sterile Solution

FDA UDI

INTERMOUNTAIN LIFE SCIENCES, LLC·B891BSSPBS1X66·

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)...

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHALICON B) SOFT (HYDROPHILIC) CONTACT LENSES

ARCHITECT STAT CK-MB IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ELEKTA OY

FDA 510(k)

FDA Class 2 ·Neurology

ORAJEL ADVANCED TOOTH DESENSITIZER

FDA 510(k)

FDA Class 2 ·Dental

NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION

FDA 510(k)

FDA Class 2 ·Dental

ARCHITECT STAT TROPONIN-1; MYOGLOBIN

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ARCHITECT STAT MYO IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Immunology