Urine Collection Apparatus System M9, M15, F15

FDA registration

Ur24Technology, Inc·1 product·🇺🇸 United States

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM/INTERSTIM II/INTERSTIM LEAD KIT PERCUTANEOUS NON-TINED/INTERSTIM TINED LEAD KIT

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Accolade Non-MRI Pacemakers: ADVANTIO, INGENIO, VITALIO, ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE

Lithotripter, Shockwave (For Treating Gallbladder Stones)

FDA Pre-Market Approval

FDA Class 3 ·MEDSTONE STS LITHOTRIPTER FOR THE TREATMENT OF SYMPTOMATIC, SOLITARY, RADIOLUCENT, NON-CALCIFIED GALLSTONES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantav Cardioverter Defibrillator (Non-CRT), Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic im

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS/RMT/EZ STEER/EZ STEER DS/NON-TEMPERATURE SENSING ABLATION/INTERFACE CABLES

Model 1550 AICD Software Module

FDA registration

Boston Scientific Corporation·2 products·🇺🇸 United States

Bioceps

FDA registration

ENDO-THERAPEUTICS, INC.·3 products·🇺🇸 United States

Covidien llc

FDA registration

Covidien llc·3 products·🇺🇸 United States

KATECHO LLC

FDA registration

KATECHO LLC·2 products·🇺🇸 United States

Vein Pick

FDA registration

Greatbatch Medical·2 products·🇺🇸 United States

CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS

FDA 510(k)

FDA Class 2 ·Radiology

LUV N' CARE, LTD.

FDA registration

LUV N' CARE, LTD.·1 product·🇺🇸 United States

Symmetry Surgical

FDA registration

Industrias Apson S.A de C.V·1 product·🇲🇽 Mexico

RXP (Rapid Exchange Flushing Syringe)

FDA registration

Merit Medical Australia Pty Ltd.·1 product·🇦🇺 Australia

QFC-853, QFC-854, QFC-850

FDA registration

KB Components Dallas, Inc.·1 product·🇺🇸 United States

FlexiFit Series HC431

FDA registration

FISHER & PAYKEL HEALTHCARE, LTD.·1 product·🇳🇿 New Zealand