APACERAM OSSICULAR PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

APACERAM HYDROXYLAPATITE DENTAL IMPLANT (TYPE G)

FDA 510(k)

FDA Class 2 ·Dental

APACERAM ARTIFICIAL DENTAL IMPLANT

FDA 510(k)

FDA Class 2 ·Dental

N-ACETYLPROCAINAMIDE (NAPA) CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VALPROIC ACID (FPIA) CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

N-ACETYLPROCAINAMIDE (NAPA) (FPIA) KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PRIMIDONE (FPIA) KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

VALPROIC ACID (FPIA) KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

PRIMIDONE (FPIA) CALIBRATOR KIT

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOC, HOMEPUMP)

FDA 510(k)

FDA Class 2 ·General Hospital

AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

HOMEPUMP, ECLIPSE, C-SERIES, PAINBUSTER, C-BLOC, ON-Q, EASYPUMP, KVO

FDA 510(k)

FDA Class 2 ·General Hospital

AOC MEDICAL SYSTEM MODEL PHASE II 50 SURGICAL DIODE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DISPOSABLE SENSOR, MULTICOMPATIBLE ENVITEC PED

FDA 510(k)

FDA Class 2 ·Cardiovascular

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·ISOTONIC STERILE UNPRESERVED SALINE SOLUTION

Analyzer, Medical Image

FDA Pre-Market Approval

FDA Class 2 ·QVCAD System (Version 3.3)

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERIDYNE SOFT (HYDROPHILIC) LENS SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·VIS-SOL STERILE PRESERVED SALINE SOLUTION

Accessories, Soft Lens Products

FDA Pre-Market Approval

FDA Class 2 ·STERILE PRESERVED SALINE SOLUTION