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