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NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

Continuous Ventilator

FDA UDI
FLIGHT MEDICAL INNOVATIONS LTD·17290013641974·F60T DL ENG-UM

Continuous Ventilator

FDA UDI
FLIGHT MEDICAL INNOVATIONS LTD·17290013641950·F60T SL Sym With Interna

Continuous Ventilator

FDA UDI
FLIGHT MEDICAL INNOVATIONS LTD·17290013641967·F60T DL ENG Int Mixer-UM

PKU INFANT HEEL WARMER

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEM·Product code MPO·July 7, 2017

RECOVER

FDA Adverse Event
Injury ·FLORIDA MEDICAL INDUSTRIES, INC.·Product code MPO·May 2, 1997

PHILIPS CHILDRENS MEDICAL VENTURES INFANT HEEL WARMER

FDA Adverse Event
Malfunction ·PHILIPS·Product code MPO·March 31, 2015

GREENLIGHT HPS LASER SYSTEM

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 22, 2013

GYRUS ACMI - PK TECHNOLOGY (PKS CUTTING FORCEPS)

FDA Adverse Event
Malfunction ·GYRUS ACMI·Product code GEI·December 15, 2008

INFANT HEEL WARMER

FDA Adverse Event
Malfunction ·CHILDRENS MEDICAL VENTURES / RESPIRONICS, INC.·Product code MPO·June 17, 2008

MICROTAINER BRAND QUIK-HEEL LANCET (INFANT)

FDA Adverse Event
Malfunction ·BECTON DICKINSON VACUTAINER SYS. MICROPETTE, INC.·Product code FMK·August 5, 1999

INFANT HEEL WARMER

FDA Adverse Event
Other ·ARGYLE·Product code MPO·October 22, 2013

SPECIMEN GATE SCREENING CENTER

FDA Adverse Event
Malfunction ·WALLAC OY, SUBSIDIARY OF PERKINELMER·Product code JQP·September 6, 2015

SMARTPHONE ANDROID APP: PUMP CONNECT

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PKU·January 17, 2023

SMARTPHONE ANDROID APP: PUMP CONNECT

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PKU·January 17, 2023

SMARTPHONE IOS APP: PUMP CONNECT

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PKU·January 15, 2023

Insulin Pump Secondary Display

FDA classification
FDA Class 2 ·Insulin Pump Secondary Display

SMARTPHONE IOS APP: PUMP CONNECT

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PKU·April 22, 2022

SMARTPHONE IOS APP: PUMP CONNECT

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PKU·May 26, 2022

SMARTPHONE ANDROID APP: PUMP CONNECT

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code PKU·May 8, 2022