NI-PACER 1

FDA 510(k)

FDA Class 2 ·Cardiovascular

ENDOXANE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MYRIAN

FDA 510(k)

FDA Class 2 ·Radiology

PREMIO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

StimQ Peripheral Nerve Stimulator (PNS) System

FDA 510(k)

FDA Class 2 ·Neurology

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder

FDA 510(k)

FDA Class 2 ·Dental

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

Freedom Spinal Cord Stimulator System

FDA 510(k)

FDA Class 2 ·Neurology

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

NeumoFilt Ergo/Neumo Filt BiteOn

FDA 510(k)

FDA Class 2 ·Anesthesiology

Oxxiom

FDA 510(k)

FDA Class 2 ·Cardiovascular

Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

FDA 510(k)

FDA Class 2 ·Neurology

FOUNDATION FRACTURE STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ENCORE ANTERIOR SPINAL STAPLE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ISOBAR SEMI-RIGID SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ISOBAR SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

HINGED KNEE

FDA 510(k)

FDA Class 2 ·Orthopedic

FOUNDATION POROUS COATED FLARED RIM SHELL

FDA 510(k)

FDA Class 2 ·Orthopedic

CEMSTOP CEMENT RESTRICTOR

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

FOUNDATION POROUS COATED HEMISPHERICAL SHELL

FDA 510(k)

FDA Class 2 ·Orthopedic