IMMUNOGLOBULINS M

FDA 510(k)

FDA Class 2 ·Immunology

KIMBERLY-CLARK® Fluidshield™ Fog-Free Procedure Mask with Splashguard™ Visor

FDA UDI

KIMBERLY-CLARK GLOBAL SALES, LLC·00036000471373·Procedure Mask with Visor

CONCEPT GRAFIX

FDA registration

CLASSIC WIRE CUT COMPANY, INC.·1 product·🇺🇸 United States

Anti Fog Solution And Accessories, Endoscopy

FDA classification

FDA Class 2 ·Anti Fog Solution And Accessories, Endoscopy

BioTop Medical

Authorized representative

🇳🇱 Netherlands·1 Manufacturer·20 Devices

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NeuroPace RNS System

FI-LOG

Importer

🇫🇷 France

ROG ARKAD

Importer

🇫🇷 France·1 Manufacturer

Oral Electronic Vision Aid

FDA classification

FDA Class 2 ·Oral Electronic Vision Aid

Bevel bobbin vent tube blue flpl 1.14mm id 6/pk

FDA registration

MIDWEST STERILIZATION CORP.·1 product·🇺🇸 United States

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO MODELS C154DWK / C164AWK CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS, CARELINK MONITOR, CARDIO SIGHT READER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO MODELS D154AWG / D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System, InterStim Micro Implantable Neurostimulator (SNS Bowel)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Bowel)

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM II IMPLANTABLE SACRAL NERVE STIMULATORS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·NEUROSTIMULATOR IMPLANTABLE INTERSTIM FAMILY

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System