BIO-FASTAK SUTURE ANCHOR

FDA registration

Arthrex Manufacturing Inc.·2 products·🇺🇸 United States

SIGNA PET/MR

FDA registration

GE Healthcare Manufacturing LLC·1 product·🇺🇸 United States

PST and accessories [Baxter]

FDA registration

Hill-Rom Company, Inc.·1 product·🇺🇸 United States

Bausch & Lomb Incorporated

FDA registration

Bausch & Lomb Incorporated·1 product·🇺🇸 United States

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Atherectomy System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL Platinum Chromium Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer II XP Cardiac Ablation Catheter and Cable

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

FDA Pre-Market Approval

FDA Class 3 ·Blazer Open Irrigated Temperature Ablation Catheter

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express SD Monorail Premounted Stent System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Chilli II Cooled Ablation Catheter and Cable

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS Elemen Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent S

CR-03-1087-817-23

Certificate

MDR QMS·Nexstim Plc·Eurofins Electric & Electronics Finland Oy

HD1137176

Certificate

MDD Annex II (excluding section 4)·JSC Vilimed·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI

EUFI29-21000160-S

Certificate

MDD Annex II (excluding section 4)·Nexstim Plc·Eurofins Electric & Electronics Finland Oy·3 Basic UDI-DIs

Zip 4 Surgical Skin Closure Device

FDA UDI

ZIPLINE MEDICAL, INC.·00853114007003·Zip 4 Surgical Skin Closure Device, BSC

Zip 24 Surgical Skin Closure Device

FDA UDI

ZIPLINE MEDICAL, INC.·00853114007034·Zip 24 Surgical Skin Closure Device, BSC

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS Systems)

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) System

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems