18 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BiopSee, Mobile US
FDA 510(k)
FDA Class 2
·Radiology
ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
BONEOPTIMIZER
FDA 510(k)
FDA Class 2
·Orthopedic
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
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014
ENDURANT
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR SANTA ROSA·Product code MIH·June 14, 2013
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CLONMEL IRELAND·Product code NVZ·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
TASUKI
FDA Adverse Event
Injury
·KANEKA CORPORATION·Product code LOX·June 6, 2019
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
Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021