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SIMPACT IMPLANT SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

IVENT 201

FDA 510(k)
FDA Class 2 ·Anesthesiology

IRRIGATION/ASPIRATION CANNULAS, VARIOUS SIZES

FDA 510(k)
FDA Class 1 ·Ophthalmic

RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F; JUGULAR/SUBCLAVAIN DELIVERY KIT, MODEL RF-320J

FDA 510(k)
FDA Class 2 ·Cardiovascular

BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

ROPHAE DIAMOND KNIFE

FDA 510(k)
FDA Class 1 ·Ophthalmic

MODIFICATION TO I VENT 201

FDA 510(k)
FDA Class 2 ·Anesthesiology

IVENT101

FDA 510(k)
FDA Class 2 ·Anesthesiology

IVENT 201 PORTABLE VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED)

FDA 510(k)
FDA Class 1 ·General Hospital

TOOTHBRUSH, POWERED

FDA registration
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

DYM060,DYM062,DYM061,DYM063,DYM064,DYM065,DYM068,DYM070,DYM071,DYM072,DYM073,DYM074,DYM076,DYM078,DYM079,DYM080

FDA registration
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

Brush, dermabrasion, powered

FDA registration
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

IRRIGATOR, POWERED NASAL

FDA registration
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

Light based over-the-counter hair removal

FDA registration
DONGGUAN DEFINE BEAUTY ELECTRONIC TECHNOLOGY CO.,LTD·1 product·🇨🇳 China

Isletest™ GAD ELISA

Basic UDI-DI
EU IVDD · Eu Ivd General ·Biomerica, Inc.·1 device

CHORUS CALPROTECTIN 3RD GENERATION

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·DIESSE Diagnostica Senese S.p.A·1 device

ElisaRSR™ GAD Ab

Basic UDI-DI
EU IVDD · Eu Ivd General ·RSR Limited·1 device

Access TSH (3rd IS)

Basic UDI-DI
EU IVDR · Eu Ivd Class B ·IMMUNOTECH SAS ·2 devices