Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·INDENTITY & IDENTITY ADX FAMILY OF DEVICES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RHYTHMIA HDx™ Ablation Connection Box (for INTELLAGEN™)

3S HEMI TOE

FDA 510(k)

FDA Class 2 ·Orthopedic

Snap-Off Self-Compressive Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

FlexitSystem Knee osteotomy system

FDA 510(k)

FDA Class 2 ·Orthopedic

IMPIX LUMBAR INTERBODY DEVICE

FDA 510(k)

FDA Class 2 ·Orthopedic

SELF- COMPRESSIVE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

STEALTH FUSION SYSTEM, MODEL RR 1000

FDA 510(k)

FDA Class 2 ·Orthopedic

WECK ELECTROSURGICAL GENERATOR #174200

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

BUTTERFLY NON-CORING NEEDLE SET

FDA 510(k)

FDA Class 2 ·General Hospital

SELF-COMPRESSIVE SCREW

FDA 510(k)

FDA Class 2 ·Orthopedic

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S

Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

FDA Pre-Market Approval

FDA Class 3 ·Oncomine Dx Target Test

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

DBS-ADX

Basic UDI-DI

EU MDR · Eu Md Class 2a ·12 devices

CDX-100

Basic UDI-DI

EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device

CDX-100

Basic UDI-DI

EU IVDD · Eu Ivd General ·Abacus Diagnostica Oy·1 device