20 results · 25ms · Sources: EU EUDAMED, US FDA

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CELLSEARCH CIRCULATING TUMOR CELL KIT

FDA 510(k)
FDA Class 2 ·Immunology

PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2

FDA 510(k)
FDA Class 2 ·Cardiovascular

BIO-EYE II ORBITAL IMPLANT

FDA 510(k)
FDA Class 2 ·Ophthalmic

VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·November 15, 2017

VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 58/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·June 22, 2018

AMISTEM H, HA COATED STEM SIZE 2 STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 9, 2017

LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER 52/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 9, 2021

DOUBLE MOBILITY LINER

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 15, 2024

LINER: VERSAFITCUP DM DOUBLE MOBILITY LINER Ø 48/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 23, 2019

COBAS 6000 E601 MODULE

FDA Adverse Event
Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·April 23, 2013

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

FDA Adverse Event
Malfunction ·AV-TEMECULA-CT·Product code DQX·May 1, 2011

TENDRIL DX

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·July 11, 2008

CUP: VERSAFITCUP ACETABULAR SHELL Ø 48

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·March 29, 2023

STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 6

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·October 16, 2020

QUADRA S FEMORAL STEMS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·June 6, 2025

VERSAFITCUP DM ACETABULAR SHELL Ø 50

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·October 24, 2015

STEM: AMISTEM H HA COATED STD STEM SIZE 5

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 5, 2022

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

FDA Enforcement
Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

Ellipse, Sterile EO, Model #/ Part #: CD1275-36/100116115; CD1275-36Q/100116116; CD1277-36/100048388, 100048391, 100060126, 100116208, 10011636; CD1277-36Q/100048374, 100048394, 100060198, 100098497, 100116268, 100116345; CD1293-36Q/100057838; CD1309-36/100057717; CD1309-36Q/100057718; CD1311-36/100057802, 100060153; CD1311-36Q/100057803, 100060174, 100116264; CD1377-36/100078796, 100079180, 100096847; CD1377-36C/100078612, 100079197, 100079368, 100116120, 100116407, 100116447; CD1377-36Q/100078747, 100079210, 100096848, 100116385, 100116423, 100116427; CD1377-36QC/100078602, 100079199, 100079229, 100116398, 100116409, 100116466,100116485, 100127151, 100127152, 100127153; CD1393-36C/100116461; CD1393-36QC/100080656, 100116339; CD1409-36Q/100080251; CD1411-36C/100080197, 100080232, 100116411, 100116481; CD1411-36Q/100080244, 100080245, 100116338, 100116464; CD1411-36QC/100116337; CD2275-36/100116355; CD2275-36Q/100116349; CD2277-36/100048359, 100048402, 100116206, 100116207; CD2277-36Q/100048377, 100048404,100060190, 100098661, 100116342, 100116350; CD2293-36/100057765; CD2293-36Q/100057766; CD2309-36/100057804; CD2309-36Q/100057763; CD2311-36/100057679, 100060100; CD2311-36Q/100057835, 100060161, 100116351; CD2377-36/100078811, 100079226, 100096774; CD2377-36C/100078601,100079225, 100079304, 100116405, 100116424, 100116484; CD2377-36Q/100078812,100079208, 100096838, 100116406, 100116414, 100116437; CD2377-36QC/100078579, 100079176, 100079352, 100116413, 100116422, 100116436, 100116482, 100127100, 100127154, 100127181; CD2393-36C/100080653, 100116416; CD2393-36QC/100080655, 100116451; CD2409-36C/100079997; CD2409-36Q/100080149; CD2411-36C/100079986, 100080104, 100116118, 100116444; CD2411-36Q/100080180, 100080230, 100116370, 100116420

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