13 results · 22ms · Sources: EU EUDAMED, US FDA

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MULTI-UNIT ABUTMENTS FOR ASTRATECH, CAMLOG AND ANKYLOS IMPLANT SYSTEMS

FDA 510(k)
FDA Class 2 ·Dental

PRECLUDE MVP DURA SUBSTITUTE

FDA 510(k)
FDA Class 2 ·Neurology

AURELUX Y 84 PREMIUM

FDA 510(k)
FDA Class 2 ·Dental

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·March 14, 2025

TRILOGY SHELL WITH HOLES

FDA Adverse Event
Malfunction ·ZIMMER·Product code LPH·April 10, 2013

ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

FDA Adverse Event
Malfunction ·MEDTORNIC IRELAND·Product code NIQ·March 16, 2011

RESTORE RECHARGEABLE NEUROSTIMULATOR

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·June 13, 2008

PINNACLE MTL INS NEUT36IDX54OD

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWA·May 7, 2013

ARTICULEZE M HEAD 36MM +1.5

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code JDI·May 7, 2013

WALLFLEX COLONIC

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MQR·December 31, 2024

CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

FDA Enforcement
Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

FDA Enforcement
Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015