12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRAXCESS DOCKING WIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
INSTANT-VIEW BARBITURATE URINE CASSETTE TEST
FDA 510(k)
FDA Class 2
·Clinical Toxicology
REVOLUTION FORMULA 2
FDA 510(k)
FDA Class 2
·Dental
INFINION 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 11, 2018
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·December 31, 2018
EVOLUT FX PLUS VALVE
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 6, 2025
1.8X18MM MDI O-BALL PROSTHETIC HEAD
FDA Adverse Event
Injury
·3M ESPE DENTAL PRODUCTS·Product code DZE·May 1, 2013
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 16, 2014
PFC SIGMA C/R NPOR FEM RT SZ 4
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·May 12, 2011
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
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
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015