Immunocytochemistry Assay, P16/Ki-67

FDA Pre-Market Approval

FDA Class 3 ·CINtec PLUS Cytology

Reherniation Reduction Device

FDA Pre-Market Approval

FDA Class 3 ·Barricaid Anular Closure Device

System, Test, Her-2/Neu, Ihc

FDA Pre-Market Approval

FDA Class 3 ·PATHWAY HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

VARIOGUIDE DRILL KIT

FDA 510(k)

FDA Class 2 ·Neurology

IMMUNODOT RUBELLA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETER

FDA 510(k)

FDA Class 2 ·Orthopedic

IMMUNODOT RUBELLA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

DESERET SPLITTABLE CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

ClearPoint System

FDA 510(k)

FDA Class 2 ·Neurology

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

FDA 510(k)

FDA Class 2 ·Neurology

VIAPIC CENTRAL LINE CATHETER

FDA 510(k)

FDA Class 2 ·General Hospital

SLH 5XC LED REF

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

SLZ 3XP DiR REF

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

SLZ 5XC Di REF

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

SLH 3XC LED - REF

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

SLZ 3XP REF (WHITE)

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

SLZ 5XP REF WHITE

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

REFERENCE SOLUTION (REF SOLN)

Device

EU IVDR · Eu Ivd Class A ·Randox Laboratories Limited·On the market

SLZ 3XC Di REF

Device

EU MDR · Eu Md Class 1 ·Keeler Ltd·On the market·1 country

Analtampon - Kegelform REF:1636

Device

EU MDR · Eu Md Class 2a ·Med SSE System GmbH·On the market·2 countries