Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·SONNET 3 (EAS) Audio Processor, MAESTRO 11

Maymom Breast Pump Accessory for Medela Breast Pumps

FDA registration

Maymom Taiwan Corp. LTD·1 product·🇹🇼 Taiwan

Maymom Pump Kit

FDA registration

Maymom Taiwan Corp. LTD·1 product·🇹🇼 Taiwan

Redsense alarm unit and sensor

FDA registration

REDSENSE MEDICAL AB·1 product·🇸🇪 Sweden

Redsense alarm system

FDA registration

REDSENSE MEDICAL AB·1 product·🇸🇪 Sweden

Redsense Medical

FDA registration

REDSENSE MEDICAL AB·1 product·🇸🇪 Sweden

Redsense home use

FDA registration

REDSENSE MEDICAL AB·1 product·🇸🇪 Sweden

Redsense Catheter Senser Patch

FDA registration

Linxens Healthcare (Tianjin) Co., Ltd·1 product·🇨🇳 China

TRACHEOSTOMY PER-FIT KIT 7MM + 2/CA Portex Per-Fit Percutaneous Tracheostomy Kit

FDA registration

Sterigenics U.S., LLC·1 product·🇺🇸 United States

Kay Pictures

Manufacturer

5 Importers

Big Home Shop Ltd

Manufacturer

ChitoTech (Keifiat Tolid Takapoo)

Manufacturer

🇮🇷 Iran·29 Basic UDI-DIs·29 Devices·Eurofins Product Testing Italy S.r.l.

SYSTHEX - SISTEMAS DE IMPLANTES OSSEO INTEGRADO LTDA

Manufacturer

🇧🇷 Brazil·313 Basic UDI-DIs·313 Devices·BSI Group The Netherlands B.V.

Gravitiq X, LLC

Manufacturer

🇺🇸 United States

Endoscope-i Ltd

Manufacturer

2 Basic UDI-DIs·35 Devices

FULL ARCH TECHNOLOGIES LIMITED

Manufacturer

The Rollens Company

Manufacturer

🇺🇸 United States·1 Basic UDI-DI·3 Devices

GTQ XII, LLC

Manufacturer

🇺🇸 United States

GTQ XIV, LLC

Manufacturer

🇺🇸 United States

GRAVITIQ VI LLC

Manufacturer

🇺🇸 United States