Orchid Safety Release Valve(TM)

FDA 510(k)

FDA Class 2 ·General Hospital

HEXLOCK SCREW

FDA 510(k)

FDA Class 2 ·Dental

POWER TRAINER WITH NEUROMUSCULAR STIMULATION

FDA 510(k)

FDA Class 2 ·Physical Medicine

T-Rex Standalone ALIF

FDA 510(k)

FDA Class 2 ·Orthopedic

MODEL 25 THERAPEUTIC ULTRASOUND -- MODIFIED

FDA 510(k)

FDA Class 2 ·Physical Medicine

NEUROLUMEN PN-1000

FDA 510(k)

FDA Class 2 ·Physical Medicine

HİBRİT FIXATOR İKİ DELİKLİ TEL SABİTLEME PINI ÇELİK (HYBRID FIXATOR TWO HOLE WIRE SECURING PIN SS)

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Ortimplant Ortopedi ve Tıbbi Aletleri Sanayi Ticaret Limited Şirketi·1 device

OHI International Limited

Authorized representative

4 Manufacturers

Immunohistochemistry Assay, Antibody, Ki-67

FDA classification

FDA Class 3 ·Immunohistochemistry Assay, Antibody, Ki-67

DIGITAL MEDICAL SCOPE

FDA UDI

NIDEK CO.,LTD.·04987669101070·The assembly system (control unit & DS-10EA Ada...

CL 096608 0010 Rev. 00

Certificate

MDD Annex V·Yiwu Ori-Power Medtech Co.,Ltd.·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

Immunocytochemistry Assay, P16/Ki-67

FDA classification

FDA Class 3 ·Immunocytochemistry Assay, P16/Ki-67

Rehaoptimal – Southeast Europe, Rok Škodlar s.p.

Importer

🇸🇮 Slovenia·1 Manufacturer

FDA Pre-Market Approval

MediBeacon® Transdermal GFR Measurement System (TGFR)

Carrier, Amalgam, Operative

FDA classification

FDA Class 1 ·Carrier, Amalgam, Operative

Handpiece, Water-Powered

FDA classification

FDA Class 1 ·Handpiece, Water-Powered

Indicator, Alumina Fluorescent, Tlc

FDA classification

FDA Class 1 ·Indicator, Alumina Fluorescent, Tlc

OKB MEDİKAL MÜHENDİSLİK YAZILIM SANAYİ TİCARET LİMİTED ŞİRKETİ

Importer

🇹🇷 Türkiye

V1 063505 0063

Certificate

IVDD Annex IV (excluding sections 4, 6)·OK biotech co., Ltd·TÜV SÜD Product Service GmbH·1 Basic UDI-DI

REHAGIRONA SLU

Importer

🇪🇸 Spain·4 Manufacturers