22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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LOGIQ S8
FDA 510(k)
FDA Class 2
·Radiology
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169595828·TRIAL 2170445 O25 IB 20MM 0 DEG 14X45
ATRAMAT
FDA UDI
Internacional Farmacéutica, S.A. de C.V.·07500142068775·ATRAMAT SILK SURGICAL SUTURE BLACK USP 4-0 EP 1...
FLEXFUSION (TM) FIXATION IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
KLASSIC HD HIP SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
MINIMAX STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 24, 2025
MINIMAX RIGHT ANATOMICAL BROACH SIZE 2
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LXH·February 20, 2020
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·May 6, 2019
RESERVOIR 1.8ML
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 14, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 14, 2013
ECHELON*FLEX45 LONG
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 21, 2011
MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 2
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code LZO·December 19, 2017
LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·April 4, 2019
CUP: MPACT ACETABULAR SHELL Ø54 TWO-HOLES
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·December 4, 2019
CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code MEH·December 27, 2019
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO 52
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 8, 2021
ASAHI GLADIUS EX
FDA Adverse Event
Malfunction
·ASAHI INTECC CO., LTD.·Product code DQX·September 17, 2025
ASAHI GLADIUS EX
FDA Adverse Event
Injury
·ASAHI INTECC CO., LTD.·Product code DQX·April 13, 2026
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·February 7, 2020
Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.
FDA Enforcement
Class II
·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020