Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM WITH C40+, C40+S, OR C40+GB IMPLANTS, AND CIS PRP+/TEMPO+ SPEECH PROCESSORS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CI24R(ST) COCHLEAR IMPLANT

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HARMONY HIRESOLUTION BIONIC EAR SYSTEM

Single-Use Internal Condom

FDA Pre-Market Approval

FDA Class 2 ·REALITY FEMALE CONDOM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·COSEAL SURGICAL SEALANT (ORIGINAL AND PRE-MIXED)

MULTI–PARAMETER PATIENT BEDSIDE MONITORS

Device

EU MDR · Eu Md Class 2b ·GE Healthcare Finland Oy·On the market·32 countries

6VT-D

Device

EU MDR · Eu Md Class 2a ·GE Vingmed Ultrasound AS·On the market·32 countries

INTERNAL ULTRASOUND SCANNERS

Device

EU MDR · Eu Md Class 2a ·GE Ultrasound Korea Ltd·On the market·32 countries

INTERNAL ULTRASOUND SCANNERS

Device

EU MDR · Eu Md Class 2a ·GE Ultrasound Korea Ltd·On the market·32 countries

INTERNAL ULTRASOUND SCANNERS

Device

EU MDR · Eu Md Class 2a ·GE Ultrasound Korea Ltd·Not intended for eu market

INTERNAL ULTRASOUND SCANNERS

Device

EU MDR · Eu Md Class 2a ·GE Ultrasound Korea Ltd·Not intended for eu market

INTERNAL ULTRASOUND SCANNERS

Device

EU MDR · Eu Md Class 2a ·GE Ultrasound Korea Ltd·On the market·32 countries

Dielectric Pad - Neck

Device

EU MDR · Eu Md Class 1 ·GE Medical Systems LLC·On the market·32 countries

FCP

Device

EU MDR · Eu Md Class 1 ·GE Medical Systems LLC·On the market·32 countries

SmartMAR

Device

EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·On the market·32 countries

ASiR-V

Device

EU MDR · Eu Md Class 2a ·GE Healthcare Japan Corporation·On the market·32 countries

Revolution Ascend Elite

Device

EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries

Revolution Ascend Plus

Device

EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries

Revolution Ascend Select

Device

EU MDR · Eu Md Class 2b ·GE Healthcare Japan Corporation·On the market·32 countries