IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT

FDA 510(k)

FDA Class 1 ·Microbiology

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System

MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Eterna SCS System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM III AT WITH APP DEVICE MODEL 7276 AND SOFTWARE MODEL9974

Prosthesis, Penis, Inflatable

FDA Pre-Market Approval

FDA Class 3 ·AMS 700 SERIES INFLATABLE PENILE PROSTHESIS (IPP) WITH AND WITHOUT INHIBIZONE TREATMENT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

Samsung ECG Monitor App with Irregular Heart Rhythm Notification

FDA UDI

Samsung Electronics Co., Ltd.·08806094948240·The Samsung ECG Monitor Application with Irregu...

Canary OR Base Station / OR PC App / OR Registration

FDA UDI

Canary Medical USA LLC·00860003118313·The OR Base Station subsystem is intended to se...

reSET® Introductory Access Limited Version (Mobile App, Android)

FDA UDI

PEAR THERAPEUTICS, INC.·10851580008156·reSET® Mobile Application running on Android. r...

Chembio DPP HIV 1/2 Rapid Test Control Pack

FDA UDI

Chembio Diagnostic Systems Inc.·00607158000045·The Chembio HIV Reactive/Nonreactive Controls a...

Samsung ECG Monitor App with Irregular Heart Rhythm Notification

FDA UDI

Samsung Electronics Co., Ltd.·08806094948233·The Samsung ECG Monitor Application with Irregu...

reSET® Introductory Access Limited Version (Mobile App, iOS)

FDA UDI

PEAR THERAPEUTICS, INC.·10851580008149·reSET® Mobile Application running on iOS. reSET...

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC GEM III AT WITH APP, DEVICE MODEL 7276 AND SOFTWARE MODEL 9974

SAS SALMONELLA H U ANTISERUM

FDA 510(k)

FDA Class 2 ·Microbiology

QUICKVUE IN-LINE ONE-STEP STREP A TEST

FDA 510(k)

FDA Class 1 ·Microbiology