LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Hemo Control (optional Add Pack Hemo Control DM)

FDA 510(k)

FDA Class 2 ·Hematology

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

FDA 510(k)

FDA Class 2 ·Cardiovascular

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·CHANGES TO ACS(R) SLALOM ADD 1.5 MM BALLOON SIZE

PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)

FDA 510(k)

FDA Class 2 ·General Hospital

FMT Reusable Temperature Probes

FDA 510(k)

FDA Class 2 ·General Hospital

MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN

FDA 510(k)

FDA Class 2 ·Dental

BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD

FDA 510(k)

FDA Class 2 ·Radiology

ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE

FDA 510(k)

FDA Class 2 ·Immunology

3M ESPE LAVA CHAIRSIDE ORAL SCANNER

FDA 510(k)

FDA Class 2 ·Dental

3M TRUE DEFINITION SCANNER

FDA 510(k)

FDA Class 2 ·Dental

LYTHOS DIGITAL IMPRESSION SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE

FDA 510(k)

FDA Class 2 ·Dental

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER

FDA 510(k)

FDA Class 2 ·Dental

BP 5000

FDA 510(k)

FDA Class 2 ·Cardiovascular

SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE

FDA 510(k)

FDA Class 2 ·Radiology

HEMOD CONCE OF VAR FORMU & LIPUID HEMOD CONCE ADD

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK

FDA 510(k)

FDA Class 2 ·Immunology

DELTA T

FDA 510(k)

FDA Class 2 ·Anesthesiology