OptraGate

FDA registration

SFS GROUP HUNGARY KFT.·1 product·🇭🇺 Hungary

Triggerfish

FDA registration

SENSIMED SA·1 product·🇨🇭 Switzerland

Air Next

FDA registration

NUVOAIR AB·1 product·🇸🇪 Sweden

Shalya EndoLUX: EndoLUX D

FDA registration

XCELLANCE MEDICAL TECHNOLOGIES PVT. LTD.·1 product·🇮🇳 India

WCS Link

FDA registration

WISE S.p.A.·1 product·🇮🇹 Italy

PSR - Peri-oral/orbital Photodamage & Rhytides

FDA registration

ENERGIST LIMITED·1 product·🇬🇧 United Kingdom

Shalya iLUX Surgical Light with Camera- Display system: iLUX 20-20 M/W/O/C-D

FDA registration

XCELLANCE MEDICAL TECHNOLOGIES PVT. LTD.·1 product·🇮🇳 India

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS QUANTITATIVE REAGENT PACK AND CALIBRATOR

Remunity

FDA UDI

United Therapeutics Corporation·00850017421073·OVER PACK, DISPOSABLE KIT, UNITY 00850017421073...

Remunity

FDA UDI

United Therapeutics Corporation·00850017421035·STARTER KIT, PHARMACY FILL, UNIT One starter ki...

Remunity

FDA UDI

United Therapeutics Corporation·00850017421097·DKPI-21128-001 SPECIALTY PHARMACY ACCESSORY KIT...

MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw

FDA 510(k)

FDA Class 2 ·Dental

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System Ascenda Intrathecal Catheters

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System. Verify Evaluation System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

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

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT ADVANCE CRYOBALLOON CATHETER

STERYLAB S.R.L.

Manufacturer

🇮🇹 Italy·1 Basic UDI-DI·1 Device·ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, ITALCERT SRL, and ITALCERT SRL

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PREPSTAIN INSTRUMENT