Fluobeam LX

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Tandem Mobi Insulin Pump with Interoperable Technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

remOVE System

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

Tandem Mobi Insulin Pump with interoperable technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Omnipod 5 ACE Pump (Pod)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tandem Mobi insulin pump with interoperable technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Tandem Mobi insulin pump with interoperable technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

t:slim X2 insulin pump with interoperable technology

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Omnipod 5 ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

iLet® ACE Pump

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

DEKA ACE Pump System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

T-SRO (TLSO), LARGE

FDA registration

TIBURON MEDICAL ENTERPRISES·1 product·🇺🇸 United States

T-SRO (TLSO), LARGE

FDA registration

Zeffer Research & Assoc. S. A. de C. V.·1 product·🇲🇽 Mexico

GYRUS ACMI, INC

FDA UDI

Gyrus Acmi, Inc.·00821925020283·WEHRS II INCUS-STAPES SINGLE NOTCH AVG Replace ...

GYRUS ACMI, INC

FDA UDI

Gyrus Acmi, Inc.·00821925020276·WEHRS II INCUS-STAPES SINGLE NOTCH AVG Replace ...

GYRUS ACMI, INC

FDA UDI

Gyrus Acmi, Inc.·00821925020320·WEHRS II INCUS-STAPES DOUBLE NOTCH AVG Replace ...

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)