20 results
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43ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS
FDA 510(k)
FDA Class 2
·General Hospital
Pads
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761968752·Pad PST 500 H G U
Hillrom™
FDA UDI
Baxter Medical Systems GmbH + Co. KG·00887761975842·Trumpf Medical/Medizin Pad PST 500 H G U
TruForm
FDA UDI
Rmo, Inc.·00885797100016·MN 1MOL BD KT STD NO/L R&L 218
Conformis Hip System
FDA UDI
Conformis, Inc.·00850268007521·IMPACTOR, FEMORAL HEAD
QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA
FDA 510(k)
FDA Class 2
·Immunology
SYNTHES (USA) WRIST FUSION PLATES (WFP)
FDA 510(k)
FDA Class 2
·Orthopedic
QUADRA BROACH SIZE 0
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code JDI·September 7, 2012
BALL HEADS: COCR BALL HEAD 12/14 Ø 32 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2019
VITROS 250 CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·April 26, 2013
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 6, 2011
RELION 1CC INS SYR 31X5/16
FDA Adverse Event
Malfunction
·TYCO HEALTHCARE/KENDALL·Product code FMF·July 17, 2008
LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER Ø 56/28
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·July 11, 2019
LINER: VERSAFITCUP CC TRIO FLAT PE HC LINER 28 / C
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·June 10, 2020
E-POLY TIBIAL BEARINGS
FDA Adverse Event
Injury
·BIOMET UK LTD.·Product code JWH·July 12, 2017
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·October 25, 2019
LINER: MPACT FLAT PE HC LINER 36/ER
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 17, 2020
MPACT LINER FLAT PE HC LINER Ø 32/D
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·January 5, 2016
CUP: MPACT ACETABULAR SHELL Ø52 MULTI-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·February 17, 2022
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018