13 results · 22ms · Sources: EU EUDAMED, US FDA

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Instylla Microcatheter

FDA 510(k)
FDA Class 2 ·Cardiovascular

Life Instruments

FDA UDI
Life Instrument Corporation·M9307191731010·Triangular Endplate Scraper 11mm, 9" Handle

MOLECULAR BREAST IMAGING SOFTWARE

FDA 510(k)
FDA Class 2 ·Radiology

AMSCO EVOLUTION MEDIUM STEAM STERILIZER

FDA 510(k)
FDA Class 2 ·General Hospital

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 31, 2018

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JKA·May 18, 2018

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 22, 2014

CARPENTIER-EDWARDS® PERIMOUNT MAGNA EASE¿ PERICARDIAL BIOPROSTHESIS

FDA Adverse Event
Injury ·EDWARDS LIFESCIENCES·Product code DYE·August 4, 2011

TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX

FDA Adverse Event
Malfunction ·INVACARE·Product code ITI·October 30, 2015

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·March 8, 2022

BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·December 10, 2019

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Enforcement
Class I ·Terminated·Dexcom Inc·April 20, 2016

Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

FDA Enforcement
Class II ·Terminated·Philips North America, LLC·March 25, 2020