46 results · 32ms · Sources: EU EUDAMED, US FDA

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HAMILTON-G5

FDA Adverse Event
Malfunction ·HAMILTON MEDICAL AG·Product code CBK·May 12, 2026

MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·March 30, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·April 27, 2026

I-STAT TROPONIN (HS-TNI ) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·January 20, 2026

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2024

MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·February 26, 2026

PUMP 1886 780G OUS BLE PUMP MG/DL

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·January 27, 2026

ABL90 FLEX PLUS ANALYZER

FDA Adverse Event
Malfunction ·RADIOMETER MEDICAL APS·Product code CHL·April 13, 2026

ALINITY I STAT HIGH SENSITIVE TROPONIN-I REAGENT KIT

FDA Adverse Event
Malfunction ·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code MMI·February 25, 2026

I-STAT CHEM8+ CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE·Product code JGS·May 27, 2026

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

BIOLOX

FDA Adverse Event
Injury ·SMITH & NEPHEW, INC.·Product code LPF·October 27, 2014

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·March 12, 2026

I-STAT TROPONIN (HS-TNI ) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·May 7, 2026

I-STAT TROPONIN (HS-TNI ) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·May 7, 2026

I-STAT TROPONIN (HS-TNI ) CARTRIDGE

FDA Adverse Event
Malfunction ·ABBOTT POINT OF CARE INC.·Product code MMI·May 7, 2026

SENSOR MMT-5120A SIMPLERA SYNC 5PK US

FDA Adverse Event
Malfunction ·MEDTRONIC MINIMED·Product code SFI·April 21, 2026

UNKNOWN NGP

FDA Adverse Event
Injury ·MEDTRONIC MINIMED·Product code OZP·January 28, 2026

BLC Ø3.75MM RB, SLA 10MM RXD

FDA Adverse Event
Injury ·INSTITUT STRAUMANN AG·Product code DZE·March 16, 2026