32 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANS SCS ACCESSORY KIT
FDA 510(k)
FDA Class 2
·Neurology
PROTON VISION
FDA 510(k)
FDA Class 2
·Radiology
TRI-FIX SPINAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·February 13, 2026
SIEMENS : ARTISTE MV
FDA Adverse Event
Malfunction
·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code IYE·July 30, 2010
EndoVive 3s Low Profile Balloon Kits Part Number: M00549390 (XMD P/N 70-0050-922) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
FDA Enforcement
Class II
·Terminated·Xeridiem Mediem Medical Devices Inc·March 2, 2016
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·April 10, 2013
CAPSURE SP NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 12, 2011
DURATA STS OPTIM
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·October 16, 2024
BD PHOENIX¿ SMIC/ID-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 1, 2024
G7 DUAL MOBILITY LINER 38MM C
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code LPH·July 12, 2022
BIOLOX DELTA OPTION HEAD, 28MM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LZO·July 13, 2022
BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
TPRLC 133 T1 PPS HO 15X150MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWL·October 25, 2021
REVISION SHELL LINER CEMENTED 0 DEGREE LINER FACE ANGLE 40 MM I.D.
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code JDI·October 26, 2021
BONE SCR 6.5X20 SELF-TAP
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BD PHOENIX¿ SMIC-101
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 28, 2025
BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH
FDA Adverse Event
Injury
·ZIMMER MANUFACTURING B.V.·Product code LPH·October 26, 2021