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

FDA Pre-Market Approval

FDA Class 2 ·CIBA CORNING ACS PSA IMMUNOASSAY

Laparoscopic Jejunostomy Kit

FDA classification

FDA Class 2 ·Laparoscopic Jejunostomy Kit

Pacing System Analyzer

FDA classification

FDA Class 2 ·Pacing System Analyzer

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

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

FDA classification

FDA Class 2 ·Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK

FDA 510(k)

FDA Class 2 ·Anesthesiology

Leone Orthodontic Implant TAD (Temporary Anchorage Device)

FDA 510(k)

FDA Class 2 ·Dental

LASERMATIC SURGILASER MODEL 5050

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST MOXIFLOXACIN 0.002-32 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST Telavancin (TLA) (0.002-32 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

FDA 510(k)

FDA Class 2 ·Microbiology

CHROMID CARBA agar (CARB)

FDA 510(k)

FDA Class 2 ·Microbiology

RAPIDEC CARBA NP

FDA 510(k)

FDA Class 2 ·Microbiology

JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

Symani Surgical System (820-03830)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Cardiovascular Suite 4.2.1

FDA 510(k)

FDA Class 2 ·Cardiovascular

JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02)

FDA 510(k)

FDA Class 2 ·Physical Medicine

Symani Surgical System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ambIT PCA*PIB, ambIT PIB, ambIT PIB*PCA, ambIT PIEB, and ambIT Programmable Intermittent Pump

FDA 510(k)

FDA Class 2 ·General Hospital