NA

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTM34082Y2Z50·

Advanced Markus

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTM340450·

NA

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTW300160·

NA

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTW340130·

Farmer

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTW30010Y10·

DIAMENTOR

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTA34028Y0Z50·

DIAVOLT

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWT430140·

NA

FDA UDI

PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH·EPTWTB34060Y2Z50·

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

FDA Pre-Market Approval

FDA Class 3 ·Edora 8, Evity 8, Enitra 8, Enticos 8 HF-T QPs,Edora 8, Evity 8, Enitra 8, Enticos 8 HF-Ts and PSW 1601.U Pacemaker/ICD/

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS FAMILY, EVIA FAMILY, ENTOVIS FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS , PHILOS, PHILOS II, EVIA, ENTOVIS, EURO EFFECTA, ESTELLA FAMILY

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·LUMAS FAMILY

Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

FDA Pre-Market Approval

FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT

Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera™ System

Prosthesis, Metatarsophalangeal Joint Cartilage Replacement Implant

FDA Pre-Market Approval

FDA Class 3 ·CARTIVA SYNTHETIC CARTILAGE IMPLANT