41 results
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23ms
·
Sources: EU EUDAMED, US FDA
Leksell Gamma Knife Icon
FDA 510(k)
FDA Class 2
·Radiology
ProLift Trial
FDA UDI
Life Spine, Inc.·00190837088873·
TX1 TISSUE REMOVAL SYSTEM
FDA 510(k)
FDA Unclassified
·Unknown
ASAHI ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
CUP: VERSAFITCUP CC TRIO 01.26.45.1156 ACETABULAR SHELL CC TRIO NO-HOLE Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·March 16, 2023
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code NAY·January 11, 2019
PINNACLE MTL INS NEUT36IDX50OD
FDA Adverse Event
Injury
·DEPUY INTL., LTD.8010379·Product code KWA·October 8, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 7, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 28, 2011
COCR BALL HEAD 12/14 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 22, 2020
BALL HEADS: COCR COCR BALL HEAD 12/14 28 SIZE M 0
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·July 24, 2020
BALL HEADS: COCR BALL HEAD 12/14 Ø 36 SIZE S -3.5
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·March 27, 2024
ROSA ONE
FDA Adverse Event
Malfunction
·MEDTECH SA·Product code OLO·March 13, 2019
MASTERLOC FEMORAL STEMS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 23, 2025
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·January 9, 2019
COCR FEMORAL BALL HEAD
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JDI·November 18, 2024
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012
LINER: MPACT FLAT PE HC LINER 36/E
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·May 25, 2021
CUP: MPACT 3D METAL ACETABULAR SHELL Ø50 TWO-HOLE
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LPH·April 5, 2022