14 results
·
28ms
·
Sources: EU EUDAMED, US FDA
LIGHT WEIGHT ALUMINUM CRUTCHES
FDA 510(k)
FDA Class 1
·Physical Medicine
STRADIS
FDA UDI
STRADIS MEDICAL, LLC·M75268214031·CUSTOM SURGICAL KIT VEIN PACK
CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET
FDA 510(k)
FDA Class 2
·Anesthesiology
HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM
FDA 510(k)
FDA Class 2
·Orthopedic
M-H HA/PC 11X160MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
M-H SOLID SHELL HA/PC DIA54MM LN24
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·March 1, 2016
MALLORY-HEAD SHORT FEMORAL STEM
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·July 28, 2017
MALLORY-HEAD ACETABULAR SHELL 54MM POUROUS + HAP COATED
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code MEH·August 11, 2016
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 20, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 5, 2015
MLRY-HD XR LAT POR FMRL 8MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·August 24, 2020
M-H HA/PC 12X165MM T1
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code LPH·December 16, 2015
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024