Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit, Obalon Navigation Balloon Kit, and Obalon Touch Balloon Kit

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SYNCHROMED REFILL KIT/BULK REFILL KIT/SYNCHROMED CATHETER ACCESS PORT (CAP) KIT

ForSure iFOB Test Set

FDA UDI

SYNTRON BIORESEARCH, INC.·00748349000021·ForSure iFOB test set Contains: 1 test device 1...

Omnipod DASH Starter Kit

FDA UDI

INSULET CORPORATION·10385082000009·Starter Kit (PDM) mg/dL - Dash, english

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·WRENCH KIT/SERVICE KIT/CAPSURE VDD LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, SERVICE KIT-PACEMAKER REPAIR KIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·LEADS SERVICE KIT & LEADS WRENCH KIT

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, SERVICE KIT PACEMAKER REPAIR KIT

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·SenSight™ Directional Lead Kit, SenSight™ Extension Kit

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE PSA KIT/ IMMULITE 2000 PSA KIT

Self-Cath Closed System

FDA registration

Coloplast Manufacturing US, LLC.·1 product·🇺🇸 United States

ISOMEDIX OPERATIONS INC

FDA registration

ISOMEDIX OPERATIONS INC·1 product·🇺🇸 United States

Urethral Kit

FDA registration

C.R. BARD, INC.·1 product·🇺🇸 United States

(confidential) Urethral Catheterization Tray (w/ or w/o Catheter)

FDA registration

CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD.·1 product·🇨🇳 China

ST AIA-PACK AFP

FDA registration

TOSOH AIA, INC.·2 products·🇯🇵 Japan

Urethral Kit

FDA registration

C.R. BARD, INC.·1 product·🇺🇸 United States

Multi-Drug test panel

FDA registration

Diagnostic Automation/ Cortez Diagnostics Inc,.·1 product·🇺🇸 United States

BD Durasafe Combined Anesthesia Kit

FDA registration

CAREFUSION 2200, INC.·2 products·🇺🇸 United States

Cath Kit

FDA registration

Medline Industries, LP - Mexicali (MXC)·1 product·🇲🇽 Mexico

Self-Cath Closed System

FDA registration

SUZHOU PROSTERI MEDICAL TECHNOLOGY CO., LTD.·1 product·🇨🇳 China