18 results · 23ms · Sources: EU EUDAMED, US FDA

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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