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

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5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS

FDA 510(k)
FDA Class 2 ·Orthopedic

LEONE SPA

FDA UDI
LEONE SPA·08033707065647·INTRAORAL ELASTICS 2,5 oz 3/16" green

N/A

FDA UDI
BIOMET MICROFIXATION, INC·00841036027759·

SunMed

FDA UDI
SUNMED, LLC·10889483033319·SunSlip Sheath Stylette - Child

SunMed

FDA UDI
SUNMED, LLC·10889483033302·SunSlip Sheath Stylette - Infant

SunMed

FDA UDI
SUNMED, LLC·10889483033326·SunSlip Sheath Stylette - Adult

HARDYDISK, KANAMYCIN, 30MCG

FDA 510(k)
FDA Class 2 ·Microbiology

ACCU-PULSE TENS UNIT

FDA 510(k)
FDA Class 2 ·Neurology

HOURGLASS

FDA Adverse Event
Injury ·MEDTRONIC·Product code MQP·June 16, 2014

EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·April 21, 2026

EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code EOQ·January 16, 2026

UNKNOWN LINER

FDA Adverse Event
Injury ·BIOMET ORTHOPEDICS·Product code JDI·February 10, 2015

PULSE GEN MODEL 103

FDA Adverse Event
Malfunction ·CYBERONICS - HOUSTON·Product code LYJ·April 11, 2025

HEART START MRX

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·April 19, 2013

HEARTMATE II LVAS

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·May 16, 2011

ASR ACETABULAR CUPS 50

FDA Adverse Event
Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·July 30, 2008

Hill-Rom brand Affinity three birthing bed

FDA Recall
Terminated ·Hill-Rom, Inc.·Product code KNC·April 24, 2003

Fortify Assura, Sterile EO, Model #/ Part #: CD1257-40/100042322, 100059623; CD1257-40Q/100042341, 100059535; CD1259-40/100041914, 100042338, 100059536, 100059646, 100081567; CD1259-40Q/100041931, 100042339, 100059537, 100059620, 100059626, 100078685; CD1263-40/100042948; CD1263-40Q/100042949; CD1357-40C/100080365, 100080377, 100083441; CD1357-40Q/100080389, 100080390, 100083388; CD1359-40/100078740, 100083267, 100096839; CD1359-40C/100078500, 100078969, 100079372, 100079373, 100083442, 100083443, 100117545; CD1359-40Q/100078804, 100079155, 100079413, 100083445, 100096884; CD1359-40QC/100078603, 100079145, 100079146, 100079239, 100083405, 100083444, 100117632, 100127000, 100127065; CD1363-40C/100080349; CD1363-40Q/100080317; CD1391-40C/100080756; CD1391-40QC/100080783; CD2257-40/100042337, 100059839; CD2257-40Q/100042342, 100059842; CD2259-40/100041893, 100042308, 100059794, 100059907, 100082567; CD2259-40Q/100041894, 100042309, 100059845, 100059873, 100078610; CD2263-40/100042950; CD2263-40Q/100043201; CD2357-40C/100080404, 100080413, 100083490; CD2357-40Q/100080319, 100080412, 100083492; CD2359-40/100078750, 100083466; CD2359-40C/100078651, 100079201, 100079240, 100079442, 100083501, 100083502, 100117546; CD2359-40Q/100078841, 100079109, 100083472; CD2359-40QC/100078652, 100079156, 100079157, 100079337, 100083407, 100083465, 100117580, 100127092, 100127103; CD2363-40C/100080416; CD2363-40Q/100080407; CD2391-40C/100080784; CD2391-40QC/100080744

FDA Enforcement
Class II ·Terminated·St Jude Medical Inc.·July 4, 2018