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

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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