Ponto Bone Anchored Hearing System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Nuance Audio Hearing Aid Software

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

QUADSENSE

FDA 510(k)

FDA Class 2 ·Neurology

TrueBalance™ Surgical System

FDA 510(k)

FDA Class 2 ·Neurology

ELIBRA SOFT-TISSUE FORCE SENSOR

FDA 510(k)

FDA Class 2 ·Neurology

ORTHOSENSOR KNEE BALANCER

FDA 510(k)

FDA Class 2 ·Neurology

XO1 Knee Balancing System

FDA 510(k)

FDA Class 2 ·Neurology

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder

FDA 510(k)

FDA Class 2 ·Neurology

ClearGuard HD Antimicrobial Barrier Cap

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Hearing Aid Feature (HAF)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

VERASENSE Knee System

FDA 510(k)

FDA Class 2 ·Neurology

CLEARGUARD HD END CAP

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

VERASENSE for Stryker Triathlon

FDA 510(k)

FDA Class 2 ·Neurology

VERASENSE for Zimmer Biomet Persona

FDA 510(k)

FDA Class 2 ·Neurology

ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM

FDA 510(k)

FDA Class 2 ·Neurology

BA310 Abutment, BIA310 Implant/Abutment

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

ELIBRA DYNAMIC KNEE BALANCER

FDA 510(k)

FDA Class 2 ·Neurology

Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Kit, Test,Alpha-Fetoprotein For Testicular Cancer

FDA Pre-Market Approval

FDA Class 2 ·ABBOTT ARCHITECT AFP FOR THE ARCHITECT I2000SR ANALYZER