14 results · 30ms · Sources: EU EUDAMED, US FDA

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CDX80

FDA 510(k)
FDA Class 2 ·Anesthesiology

MASIMO SET RAD 57 PULSE CO-OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)

FDA 510(k)
FDA Class 2 ·Radiology

RED DCI-DC3 SENSOR

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·September 15, 2015

RD SET GE - 12

FDA Adverse Event
Malfunction ·Product code DQA·August 13, 2021

RD SET DCI

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·February 17, 2017

MICRO OSCILLATING SAW

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·June 2, 2014

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·November 21, 2012

LEAD MODEL 302

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·September 1, 2010

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

KIT, RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code DQA·May 10, 2019

RD SET NEO CS-3

FDA Adverse Event
Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018