21 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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