InSePtion MIS Fixation System

FDA UDI

Kalitec Direct LLC·B07314K0600100·Tray Insert, ISP Instrument Prep

InTess Lumbar Cage

FDA UDI

Kalitec Direct LLC·B07312K0600100·Tray Insert, Trials

CosmoLock Pedicle Screw System

FDA UDI

Kalitec Direct LLC·B07311K0600100·Tray Insert, Lumbar Instruments, 2

InTess Lumbar Cage

FDA UDI

Kalitec Direct LLC·B07312K0600090·Tray Insert, Level II

Cosmolock

FDA UDI

Kalitec Direct LLC·B07311K0600120·Tray Insert 5, Cosmolock Deformity

SINGLE SIZE TENDON SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

STERILE SUBDERMAL NEEDLE ELECTRODES

FDA 510(k)

FDA Class 2 ·Neurology

Ampere™ Generator Kit

FDA registration

St. Jude Medical, Atrial Fibrillation Division, Inc.·2 products·🇺🇸 United States

Ampere™ Generator Kit

FDA registration

St. Jude Medical, Cardiology Division, Inc.·2 products·🇺🇸 United States

Ampere™ Generator Kit

FDA registration

IRVINE BIOMEDICAL. INC.·2 products·🇺🇸 United States

Ampere™ Generator Kit

FDA registration

St. Jude Medical·2 products·🇺🇸 United States

Cool Point Irrigation Pump

FDA registration

MERIT MEDICAL SYSTEMS, INC.·1 product·🇺🇸 United States

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Cool Point Tubing Set

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path Ablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETERS

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Cool Path Ablation Catheter

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·SAFIRE BLU AND THERAPY COOL PATH BI-DIRECTIONAL ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH CATHETER(6 HOLE IRRIGATED) AND BI-DIRECTIONAL, SAFIRE BLU (6HOLE IRRIGATED) SAFIRE BLUE SP AND THERAPY

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER & IBI 1500T9