16 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EchoPAC Software Only, EchoPAC Plug-in
FDA 510(k)
FDA Class 2
·Radiology
TRIAL CABLE, 3009
FDA 510(k)
FDA Class 2
·Neurology
SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30
FDA 510(k)
FDA Class 2
·Radiology
COMFORT TOUCH INSUIN PEN NEEDLES
FDA Adverse Event
Malfunction
·JIANGSU CAINA TECHNOLOGY CO., LTD.·Product code FMI·May 21, 2021
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 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 14, 2014
V-PRO STERILIZER
FDA Adverse Event
STERIS MEXICO, S. DE R.L. DE C.V.·Product code MLR·June 14, 2013
ACCU-CHEK SPIRIT CARTRIDGE
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·June 22, 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
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024