12 results · 21ms · Sources: EU EUDAMED, 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