ROSA Bracket

FDA 510(k)

FDA Class 2 ·Dental

gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

FDA 510(k)

FDA Class 2 ·Dental

DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500

FDA 510(k)

FDA Class 2 ·Immunology

VENUS Bracket, ROSE Bracket

FDA 510(k)

FDA Class 2 ·Dental

gentleheel® Adult Incision Device

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

IMX HOMOCYSTEINE

FDA 510(k)

FDA Class 2 ·Immunology

ComfortGuard Surgical Isolation Gown

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MODIFICATION TO IMX HOMOCYSTEINE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

FDA Pre-Market Approval

FDA Class 2 ·ACCESS HYBRITECH PSA REAGENTS ACCESS IMMUNOASSAY SYSTEMS

FLEXLAB 3.6, ACCELERATOR A3600

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

ULTRASONIC SCALER

FDA 510(k)

FDA Class 2 ·Dental

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA

FDA 510(k)

FDA Class 2 ·Immunology

ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

AFINION ANALYZER

FDA 510(k)

FDA Class 2 ·Hematology

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

FDA 510(k)

FDA Class 2 ·Immunology

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

FDA 510(k)

FDA Class 2 ·Hematology