17 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRAUMANN DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
CLIRANS E-SERIES DIALYZER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
INFINITY ETCO2 + RESPIRATORY MECHANICS POD
FDA 510(k)
FDA Class 2
·Anesthesiology
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
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·April 29, 2013
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·May 10, 2011
NOVAMAX LINK GLUCOSE MONITOR
FDA Adverse Event
Other
·NOVA BIOMEDICAL CORP.·Product code NBW·July 25, 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
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
Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·July 1, 2015
On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc.·April 30, 2014
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018