2,619 results · 43ms · Sources: EU EUDAMED, US FDA

SPAC TM T4 RIA KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval
FDA Class 3 ·VENTANA PD-L1 (SP263) Assay

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Quartet, Victory, Zephyr, Accent, Assurity, Assurity+Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL D

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·VENTRITEX SPL/TVL LED SYSTEM/ADX LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·IDENTITY ADX FAMILY OF PACEMAKERS SYNCHRONCY DEVICE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·INDENTITY & IDENTITY ADX FAMILY OF DEVICES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval
FDA Class 3 ·Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL and Sustain XL DC, S

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP System

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP and Impella RP with SmartAssist

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·Floseal Hemostatic Matrix

Computer-Assisted Personalized Sedation System

FDA Pre-Market Approval
FDA Class 3 ·SEDASYS COMPUTER ASSISTED PERSONALIZED SEDATION SYSTEM

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist and RP Flex with SmartAssist

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·Floseal Hemostatic Matrix

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·HEMOBLAST™ Bellows

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval
FDA Class 3 ·Impella RP, Impella RP with SmartAssist

Absorbable Collagen Hemostatic Agent With Thrombin

FDA Pre-Market Approval
FDA Class 3 ·Floseal Hemostatic Matrix