Cytomegalovirus (Cmv) Dna Quantitative Assay

FDA Pre-Market Approval

FDA Class 2 ·ARTUS CMV RGQ MDX KIT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK SQ PATCH LEAD/SQ ARRAY LEAD/SQ ARRAY XP/SMALL & LARGE PATCH LEADVENTAK NINI III/IV/ AICD PULSE GENERATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK SQ LEAD ARRAY MODEL 0048 AND ENDOTAK SQ LEAD PATCH MODEL 0063

Custom Monty 3D Swing Away QS Sturdy

Device

EU MDR · Eu Md Class 1 ·Rehadapt GmbH·On the market

L3D 10-Base SK Connect 10 QS

Device

EU MDR · Eu Md Class 1 ·Rehadapt GmbH·On the market·15 countries

L3D 16-Base SK Connect 16 QS

Device

EU MDR · Eu Md Class 1 ·Rehadapt GmbH·On the market·15 countries

FULL BODY RESTRAINT SYSTEM

FDA 510(k)

FDA Class 1 ·General Hospital

TITANIUM HEMOSTATIC CLIP

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

MEDSOL GOLDENBERG BONE MARROW BIOPSY NEEDLE

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

ANT MODEL 1

FDA 510(k)

FDA Class 2 ·Radiology

aprevo Intervertebral Body Fusion Device

FDA 510(k)

FDA Class 2 ·Orthopedic

aprevo Transforaminal IBF

FDA 510(k)

FDA Class 2 ·Orthopedic

LEBO

FDA registration

BIOMATERIALS KOREA INC.·1 product·🇰🇷 South Korea

Pack QS5

Basic UDI-DI

EU MDD · Eu Md Class 2a ·Dentalhitec·1 device

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD

SPOTLIGHT

FDA UDI

DEPUY SPINE, LLC·10705034358994·SPOTLIGHT PL RETRACTOR HANDLE

SPOTLIGHT

FDA UDI

DEPUY SPINE, LLC·10705034359076·SPOTLIGHT PL BLADE RIGHT 50mm

SPOTLIGHT

FDA UDI

DEPUY SPINE, LLC·10705034359380·SPOTLIGHT PL LIGHTED BLADE RIGHT 80mm

SPOTLIGHT

FDA UDI

DEPUY SPINE, LLC·10705034359298·SPOTLIGHT PL LIGHTED BLADE LEFT 50mm

SPOTLIGHT

FDA UDI

DEPUY SPINE, LLC·10705034359168·SPOTLIGHT PL BLADE MIDDLE 80mm