TRIEEA31XT

FDA registration

BRDH·2 products·🇳🇱 Netherlands

OMS-PDB1000

FDA registration

BRDH·1 product·🇳🇱 Netherlands

AR-1588RT

FDA registration

BRDH·1 product·🇳🇱 Netherlands

AR-2271

FDA registration

BRDH·1 product·🇳🇱 Netherlands

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Automatic Hematology Analyzer F-DR Diluent

Basic UDI-DI

EU IVDR · Eu Ivd Class A ·Maccura Biotechnology Co., Ltd. ·1 device

Mobile X-ray System FDR Go

Basic UDI-DI

EU MDD · Eu Md Class 2b ·Shimadzu Corporation·1 device

ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM

FDA 510(k)

FDA Class 2 ·Dental

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROFILE(TM) MD (MODELS V-186F AND V-186HV3), PHOTON(TM) DR (MODEL V-230HV) AND PHOTON(TM) U VR/DR IMPLANTABLE CARDIOVER)

Anovo Surgical System (Model 6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROLINK ADHESIVES (PROLINK, PROLINK SE)

FDA 510(k)

FDA Class 2 ·Dental

NOVA Dental Implants System

FDA 510(k)

FDA Class 2 ·Dental

iTind System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PROFIL COMPOSITES (PROFIL, PROFIL FLOW)

FDA 510(k)

FDA Class 2 ·Dental

Anovo Surgical System (6Ne)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ABC Dental Implant System

FDA 510(k)

FDA Class 2 ·Dental

XENX STONE MANAGEMENT DEVICE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

NEATSTITCH NEATCLOSE SUTURING DEVICE

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PROGLASS CEMENTS (ONE, TWO TWO LC, NINE, PLUS, SILVER)

FDA 510(k)

FDA Class 2 ·Dental

Anovo Pedestal

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery