MRI Interventions

FDA UDI

Clearpoint Neuro, Inc.·00850359007591·Hex Key, 5 mm, MR Conditional

ClearPoint

FDA UDI

Clearpoint Neuro, Inc.·00850359007652·SmartFrame XG TwistPoint Kit 4.5 and 3.4 Bits -...

ClearPoint

FDA UDI

Clearpoint Neuro, Inc.·00850359007508·ClearPoint Fiberoptic 40" Monitor w-Mouse System

SmartFrame

FDA UDI

Clearpoint Neuro, Inc.·00850359007164·SMARTFrame Hand Controller

MRII

FDA UDI

Clearpoint Neuro, Inc.·00850359007294·Flexible Self Adhesive Equipment Cover,16 x 24,...

ClearPoint

FDA UDI

Clearpoint Neuro, Inc.·00850359007607·ClearPoint Procedure– Software Version 2.0

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

API ANAIDENT

FDA 510(k)

FDA Class 1 ·Microbiology

API ZYM

FDA 510(k)

FDA Class 1 ·Microbiology

API 3S

FDA 510(k)

FDA Class 1 ·Microbiology

API 20GP

FDA 510(k)

FDA Class 1 ·Microbiology

API 20A

FDA 510(k)

FDA Class 1 ·Microbiology

API MDS*

FDA 510(k)

FDA Class 1 ·Clinical Chemistry

API 20C

FDA 510(k)

FDA Class 1 ·Microbiology

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Surmodics SurVeil Drug-Coated Balloon

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·CPI SWITCH BOX

METICULY Patient-specific titanium maxillofacial mesh implant

FDA registration

METICULY CO., LTD.·1 product·🇹🇭 Thailand

METICULY CO., LTD.

FDA registration

METICULY CO., LTD.·1 product·🇹🇭 Thailand

RETISCAN, RETIPORT

FDA 510(k)

FDA Class 2 ·Neurology

InnoVoyce VYLO

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery