115 results · 29ms · Sources: EU EUDAMED, US FDA

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System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-ROCHE(R) EIA

NUCLEUS 22

FDA Adverse Event
Injury ·COCHLEAR LIMITED·Product code MCM·May 18, 2025

NA

FDA UDI
Richard Wolf GmbH·04055207043585·TEM OBTURATOR Ø 36MM WL 175MM WL 175mm, reusable

NAR

FDA UDI
NORTH AMERICAN RESCUE, LLC·10842209121820·

NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

FDA Adverse Event
Malfunction ·COCHLEAR LTD.·Product code MCM·August 23, 2016

OPERATING ROOM STAND

FDA 510(k)
FDA Class 1 ·General, Plastic Surgery

Sealant, Dural

FDA Pre-Market Approval
FDA Class 3 ·SpineSeal Spine Sealant

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS

COULTER LH 500 HEMATOLOGY ANALYZER

FDA Adverse Event
Malfunction ·BECKMAN COULTER·Product code GKZ·May 30, 2014

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 20, 2012

ENDOPATH** XCEL* STABILITY SLEEVE FOR BLADELESS TROCAR

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·September 21, 2010

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval
FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS