Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia System

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Bonebridge

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Active Implantable Bone Conduction Hearing System

FDA classification

FDA Class 2 ·Active Implantable Bone Conduction Hearing System

HFO SHOULDER COIL

FDA 510(k)

FDA Class 2 ·Radiology

SANICURE DISPOSABLE CURING PROBE

FDA 510(k)

FDA Class 2 ·Dental

ENA HFO COMPOSITE SYSTEM

FDA 510(k)

FDA Class 2 ·Dental

LightForce Orthodontic System (LFO System)

FDA 510(k)

FDA Class 2 ·Dental

GISH RELIANCE OXYGENATOR (MODEL HFO)

FDA 510(k)

FDA Class 2 ·Cardiovascular

PAO BIPOLAR COAXIAL COAGULATOR (55-P15C/55-P18C/55-P18S/55-P19S/55-P20S)

FDA 510(k)

FDA Class 2 ·Ophthalmic

SIGNA MFO/I MAGNETIC RESONANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology

SIGNA HFO/I MAGNETIC RESONANCE SYSTEM

FDA 510(k)

FDA Class 2 ·Radiology