Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·coflex® Interlaminar Technology

Delica

FDA UDI

Shenzhen Delica Medical Equipment Co., Ltd.·06970481940109·

Delica

FDA UDI

Shenzhen Delica Medical Equipment Co., Ltd.·06970481940093·

Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir

FDA registration

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·4 products·🇺🇸 United States

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir

FDA registration

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·4 products·🇺🇸 United States

OXY-1 System

FDA registration

Breethe, Inc.·4 products·🇺🇸 United States

3CX*RX15RW40 Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating

FDA registration

Sterigenics U.S., LLC·4 products·🇺🇸 United States

CAPIOX FX Advance Oxygenators and Reservoirs Series 4Liter

FDA registration

Sterigenics U.S., LLC·4 products·🇺🇸 United States

Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir

FDA registration

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·4 products·🇺🇸 United States

TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR

FDA registration

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION·4 products·🇺🇸 United States

3CX*FX25RWC

FDA registration

Sterigenics U.S., LLC·4 products·🇺🇸 United States

OXY-1 System

FDA registration

ABIOMED, INC.·4 products·🇺🇸 United States

3CX*FX15RW30 Capiox FX15 Oxygenator with Arterial Filter

FDA registration

Sterigenics U.S., LLC·4 products·🇺🇸 United States

HIT-Set Advanced 7 and 5 (SOFTLINE Coating)

FDA registration

MAQUET CARDIOPULMONARY GmbH·4 products·🇩🇪 Germany

QUADROX-iR Adult and Small Adult Oxygenator with Holding Clamp

FDA registration

Sterigenics Belgium Petit Rechain S.A.·4 products·🇧🇪 Belgium

Metze SAS

Importer

🇫🇷 France

MTS Medizintechnische Servicegesellschaft mbH

Importer

🇩🇪 Germany·1 Manufacturer

AIRO Suction Unit (AIRO-01)

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

XP TECHNOLOGY ULTRASONIC SCALER

FDA 510(k)

FDA Class 2 ·Dental

EZTEST-GAS

FDA 510(k)

FDA Class 2 ·General Hospital