Intersept®

FDA UDI

MEDTRONIC, INC.·00681490465939·FILTER CB1P00R 2PK CB 20M W/LOOP

5 TOE MOISTURIZING BOOTIES

FDA registration

POLYGEL LLC.·1 product·🇺🇸 United States

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP CARDIAC ABLATION CATHETER/CABLE/BLAZER II HIGH TORQUE DISTAL (HTD) ABLATION CATHETER/CABLE/BLAZER PRIME

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

84587CE01

Certificate

MDD Annex II (excluding section 4)·HTL-Strefa S.A.·TÜV Rheinland LGA Products GmbH·7 Basic UDI-DIs

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYMBIOS, SYNERGYST

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PASYS, PASYS ST, SPECTRAX S, SPECTRAX SX, SPECTRAX SX-HT, SPECTRAX SXT, SYSMBIOS, SYNERGYST