GUIDELINES FOR PEDIATRIC ANESTHESIA

FDA 510(k)

FDA Class 2 ·Anesthesiology

ProCell Surgical Sponge-Blood Recovery Unit

FDA 510(k)

FDA Class 2 ·Anesthesiology

INTRAOPERATIVE AUTOTRANSFUSION SYS

FDA 510(k)

FDA Class 2 ·Anesthesiology

TRAUMA DRAINAGE SET 72T-32TTC

FDA 510(k)

FDA Class 2 ·Anesthesiology

XTRA

FDA 510(k)

FDA Class 2 ·Anesthesiology

IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI

FDA 510(k)

FDA Class 2 ·Anesthesiology

PLEUR-EVAC II AUTOTRANSFUSION SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM MODEL 900500 1, AT1 AUTOTRANSFUSION SET MODEL 900 510 1, PSQ SET (DD) MODEL 61

FDA 510(k)

FDA Class 2 ·Anesthesiology

DAVOL ATS

FDA 510(k)

FDA Class 2 ·Anesthesiology

RECEPTAL ATS MEDIASTINAL LINER

FDA 510(k)

FDA Class 2 ·Anesthesiology

PulseLavage AB

Manufacturer

🇸🇪 Sweden·5 Basic UDI-DIs·5 Devices·UDEM Adriatic d.o.o., UDEM Adriatic d.o.o., and Eurofins Electric & Electronics Finland Oy

Shenzhen Zijian Biotechnology Co., Ltd

Manufacturer

🇨🇳 China·287 Basic UDI-DIs·368 Devices·SGS Belgium NV and CeCert Sp. z o.o.

RICHARD WOLF GMBH

FDA registration

RICHARD WOLF GMBH·3 products·🇩🇪 Germany

BCM 400CP

FDA 510(k)

FDA Class 2 ·Radiology

BCM-400C

FDA 510(k)

FDA Class 2 ·Radiology

ARC-600

FDA 510(k)

FDA Class 2 ·Radiology

BCM-ARC 105 X-RAY MOBILE UNIT

FDA 510(k)

FDA Class 2 ·Radiology

BCM-600TX

FDA 510(k)

FDA Class 2 ·Radiology

SPINOSCOPE

FDA 510(k)

FDA Class 2 ·Physical Medicine

ISOMEDIX OPERATIONS INC.

FDA registration

ISOMEDIX OPERATIONS INC.·1 product·🇺🇸 United States