20 results
·
20ms
·
Sources: EU EUDAMED, US FDA
OLYMPUS RETRACTABLE VALVULOTOME
FDA 510(k)
FDA Class 2
·Cardiovascular
Preat
FDA UDI
Preat Corporation·00842092111826·Hex Tube and Screw 1.2mm Short
DeRoyal
FDA UDI
DEROYAL INDUSTRIES, INC.·00749756020787·FULL LEG SPLINT
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE
FDA 510(k)
FDA Unclassified
·Unknown
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
FDA 510(k)
FDA Class 2
·Neurology
MICROTAINER SST GOLD
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·June 7, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 1, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 16, 2018
MICROTAINER SST GOLD
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD·Product code JKA·May 7, 2018
BD MICROTAINER® EDTA LAVENDER TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·April 27, 2018
BD MICROTAINER® EDTA LAVENDAR TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·May 3, 2018
BD MICROTAINER® BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BD CARIBE LTD.·Product code JKA·December 3, 2017
COBAS 8000 E602 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 11, 2013
RESTORE ULTRA
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 29, 2010
INGENIO
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 3, 2014
VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code LQM·September 13, 2018
VITEK® 2 GRAM NEGATIVE IDENTIFICATION TEST KIT
FDA Adverse Event
Malfunction
·BIOMERIEUX INC.·Product code LQM·September 13, 2018
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015
Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 7, 2014
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015