Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone)

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP) with and without InhibiZone™

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

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App

FDA 510(k)

FDA Class 2 ·Microbiology

reSET-O® Demo Version (Mobile App, iOS)

FDA UDI

PEAR THERAPEUTICS, INC.·10851580008231·reSET-O® Mobile Application running on iOS. reS...

reSET-O® Demo Version (Mobile App, Android)

FDA UDI

PEAR THERAPEUTICS, INC.·10851580008248·reSET-O® Mobile Application running on Android....

Rely.a.Bondhttps://gudid.fda.gov/gudid/app/admin/udi/manageDI.xhtml?pageDataLoad

FDA UDI

RELIANCE ORTHODONTIC PRODUCTS INC·D79811GRPP0·Rely•a•Bond® is intended for use in bonding met...

Active Anthrax Detect™ Plus Rapid Test

FDA registration

INBIOS INTERNATIONAL, INC.·1 product·🇺🇸 United States

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Liberta RC Deep Brain Stimulation (DBS) and NeuroSphere Digital Health App

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Eterna Spinal Cord Simulation Implantable Pulse Generator (IPG) and NeuroSphere Digital Health App

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700™ Inflatable Penile Prosthesis (IPP) with and without lnhibiZone ™ Treatment