13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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