21 results · 23ms · Sources: EU EUDAMED, US FDA

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PRESSUREWIRE; CERTUS, CERTUS 300, AERIS, AERIS 300

FDA 510(k)
FDA Class 2 ·Cardiovascular

ArgenIS

FDA UDI
ARGEN CORPORATION, THE·D818131452·MUA NC NP 3.5GH Ang17

CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW

FDA 510(k)
FDA Class 2 ·Radiology

ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03

FDA 510(k)
FDA Class 2 ·Orthopedic

980 VENTILATOR

FDA Adverse Event
Malfunction ·COVIDIEN·Product code CBK·December 14, 2016

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC 12/14 Ø 28 SIZE L

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

MPACT DM DOUBLE MOBILITY HC LINER Ø 50/28

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 30, 2019

LINER: MPACT DM DOUBLE MOBILITY HC LINER 22.2/DMC

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·December 7, 2020

MEDTRONIC LUMBAR PERITONEAL SHUNT VALVE

FDA Adverse Event
MEDTRONIC, INC.·Product code JXG·May 28, 2013

CAPSUREFIX NOVUS

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

ENDOTAK RELIANCE

FDA Adverse Event
Injury ·CPI - DEL CARIBE·Product code NVY·October 1, 2014

STEALTHSTATION® S7´

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019

LINER: MPACT DM DM CONVERTER TIN COATED D/DMB

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·June 27, 2024

STEM: M-VIZION PROXIMAL BODY Ø20MM L 90MM STD

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 9, 2024

CUP: MPACT ACETABULAR SHELL Ø56 MULTI-HOLE

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·March 1, 2022

BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 13, 2022

MPACT DOUBLE MOBILITY SHELLS

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LPH·February 21, 2024

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015