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

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Miria Skin Treatment System

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY

FDA 510(k)
FDA Class 2 ·Cardiovascular

FINGERTIP PULSE OXIMETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

BD SYRINGE 3ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 23, 2023

SYRINGE 3ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 28, 2023

SYRINGE 3ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 27, 2023

BD SYRINGE 3ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 30, 2023

SOLETRA

FDA Adverse Event
Malfunction ·IPG MFG SWITZERLAND·Product code MHY·January 6, 2012

UNKNOWN DISCOVER ARTIFICIAL DISC

FDA Adverse Event
Injury ·DEPUY SYNTHES SPINE·Product code ODP·May 16, 2017

UNKNOWN DISCOVER ARTIFICIAL DISC

FDA Adverse Event
Injury ·DEPUY SYNTHES SPINE·Product code ODP·May 16, 2017

UNKNOWN DISCOVER ARTIFICIAL DISC

FDA Adverse Event
Injury ·DEPUY SYNTHES SPINE·Product code MRW·May 16, 2017

UNKNOWN DISCOVER ARTIFICIAL DISC

FDA Adverse Event
Injury ·DEPUY SYNTHES SPINE·Product code KWQ·May 16, 2017

BD SYRINGE 3ML LL BNS

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·May 26, 2024

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

INTERSTIM II

FDA Adverse Event
Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·August 18, 2011

VERSACARE BED

FDA Adverse Event
Malfunction ·HILL-ROM, INC.·Product code FNL·July 2, 2013

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

FDA Enforcement
Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026