FDA Pre-Market Approval

CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II DF-4 CRT-D, MAXIMO II DF-4 ICD, MAXIMO II ICD, PROTECTA DF4-ICD, PROTECTA ICD, PROTECTA XT DF-4 ICD, PROTECTA

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

AQUASOFT ALL-DAY & ALL-DAY T (HIOXIFILCON A) DAILY WEAR CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

ALL-BOND DENTIN BONDING SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

CUSHIONS, DENTURE ADHESIVE, ALL-DAY

FDA 510(k)

FDA Class 2 ·Dental

PHYCON ALL SILICONE BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

EXACTECH ALL POLY ACETABULAR CUP

FDA 510(k)

FDA Class 1 ·Orthopedic

SILICATH ALL SILICONE FOLEY CATHETER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ICONIX TT All Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

TECNOL SECURE-ALL TUBE HOLDER

FDA 510(k)

FDA Class 1 ·Gastroenterology, Urology

WATERLASE IPLUS ALL TISSUE LASER

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

EXETER ALL PLASTIC ACETABULAR COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

LACEY ALL POLYETHYLENE TIBIAL COMPONENT

FDA 510(k)

FDA Class 2 ·Orthopedic

Shadow Knotless All-Suture Anchors

FDA 510(k)

FDA Class 2 ·Orthopedic

HEMOTOLOGY PRODU&TS (5 IN ALL)

FDA 510(k)

FDA Class 2 ·Hematology

STELKAST ALL POLYETHYLENE ACETABULAR CUP

FDA 510(k)

FDA Class 2 ·Orthopedic

HEARING AID (ALL-IN-EAR)

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

FILT-R-ALL BACTERIAL FILTER

FDA 510(k)

FDA Class 2 ·Anesthesiology

NEXGEN PROLONG ALL-POLY PATELLA

FDA 510(k)

FDA Class 2 ·Orthopedic