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

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IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C

FDA 510(k)
FDA Class 1 ·Clinical Chemistry

icotec Cervical Cage, Anatomic Probe, 8 mm x 18 mm

FDA UDI
icotec AG·07640140438931·icotec Cervical Cage, Anatomic Probe, 8 mm x 18 mm

ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

FDA 510(k)
FDA Class 1 ·Microbiology

MEDLINE STRIDER MINI 3

FDA 510(k)
FDA Class 2 ·Physical Medicine

CADD ADMINISTRATION SET

FDA Adverse Event
Malfunction ·ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V·Product code FPA·March 26, 2026

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7 HANDHELD

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·November 18, 2014

RADICAL-7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·February 19, 2016

SEDLINE KIT

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code MWI·January 8, 2017

HARMONIC ACE

FDA Adverse Event
Malfunction ·STRYKER SUSTAINABILITY SOLUTIONS·Product code LFL·May 31, 2013

INSULIN INFUSION PUMP

FDA Adverse Event
Death ·MEDTRONIC MINIMED·Product code OYC·October 3, 2014

STAIR PRO - MODEL 6252

FDA Adverse Event
Malfunction ·STRYKER MEDICAL·Product code FPP·May 31, 2011

RADICAL-7

FDA Adverse Event
Malfunction ·MASIMO CORPORATION·Product code DQA·July 9, 2015

SEDLINE KIT

FDA Adverse Event
Malfunction ·MASIMO - 40 PARKER·Product code GWQ·July 21, 2017

VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H

FDA Enforcement
Class II ·Terminated·Zimmer Biomet, Inc.·June 21, 2017