106 results · 20ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·CEA-RIA MONOCLONAL

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA ONE-STEP

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT IMX-CEA (LIST 3A33)

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT CEA-EIA KIT

System, Test, Carcinoembryonic Antigen

FDA Pre-Market Approval
FDA Class 2 ·ABBOTT AXSYM CEA (LIST 7A47)

ECG Cable Adaptor-for use with V10-0017 (Model TS3)

FDA UDI
VASOMEDICAL, INC.·00817980020900·ECG Cable Adaptor (Model TS3 – for use with V1...

iNSitu™ Hip System

FDA UDI
NEXTSTEP ARTHROPEDIX, LLC·00816127020797·Full Hemisphere Reamer Size 66

SABOURAND DEXTROSE AGAR

FDA 510(k)
FDA Class 1 ·Microbiology

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·COSMOS(TM) SYSTEM

ONETOUCHPING GLUCOSEMGMTSYSTEM

FDA Adverse Event
Malfunction ·ANIMAS CORPORATION·Product code LZG·May 23, 2014

INFUSE BONE GRAFT

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·November 13, 2012

FLUOROSCOPY STRETCHER

FDA Adverse Event
Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code FPO·September 7, 2010

Respirator Crash Cart Kit

FDA Enforcement
Class II ·Terminated·ROi CPS LLC·July 8, 2020

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·NOVA II MODEL 282-04Y PULSE GENERATOR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval
FDA Class 3 ·IMPLANTABLE PACEMAKER