17 results · 29ms · Sources: EU EUDAMED, 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