MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

PERSONAL INFUSION PUMP

FDA 510(k)

FDA Class 2 ·General Hospital

CURIEPACS (DICOM PACS SOFTWARE)

FDA 510(k)

FDA Class 2 ·Radiology

EXTRACORPOREAL BLOOD CIRCUIT

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PER, MODEL MEMO

FDA 510(k)

FDA Class 2 ·Cardiovascular

Mirror handle 28 ES red UNF4-48 DTS U

Device

EU MDR · Eu Md Class 1 ·LM-Instruments Oy·On the market·32 countries

Withings®

FDA UDI

WITHINGS·03700546708664·

CRAIGWELL AID HA300

FDA 510(k)

FDA Class 1 ·Ear, Nose, Throat

3nethra neo

FDA 510(k)

FDA Class 2 ·Ophthalmic

CRAIGWELL AID FITTING SYSTEM AFS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

CRAIGWELL MASTER HEARING AID MHA

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

NRS

Importer

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT

ESR Pipette Set

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Zhejiang Sorfa Life Science Research Co., Ltd.·1 device

Visualsed ESR Rack

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Linear Chemicals S.L.U·1 device

ESR Fast Detector

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Guangzhou Improve Medical Instruments Co., Ltd·1 device

VISION ESR Analyzer

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·1 device

VISION ESR Analyzer

Basic UDI-DI

EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·1 device