27 results · 24ms · Sources: EU EUDAMED, US FDA

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SMV Scientific 4.5 mm Bone Screws

FDA 510(k)
FDA Class 2 ·Orthopedic

DIAZYME GLYCATED SERUM PROTEIN ASSAY / CALIBRATOR KIT / CONTROL KIT

FDA 510(k)
FDA Class 2 ·Hematology

EPIGUARD

FDA 510(k)
FDA Class 2 ·Neurology

CD HORIZON SPINAL SYSTEM

FDA Adverse Event
Injury ·WARSAW ORTHOPEDICS·Product code NKB·July 21, 2017

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

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 7, 2014

UPHOLD VAGINAL SUPPORT SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 6, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 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

MICROVASCULAR PLUG

FDA Adverse Event
Injury ·REVERSE MEDICAL·Product code KRD·September 8, 2021