13 results · 19ms · Sources: EU EUDAMED, US FDA

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IDEIA PCE CHLAMYDIA

FDA 510(k)
FDA Class 1 ·Microbiology

Baltic Denture System BDLoad

FDA UDI
Merz Dental GmbH·D7091033865·Baltic Denture System BDLoad BDLoad ↓ Lw6 PLSEu...

COBAS INTEGRA AMPHETAMINES

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

TIP DEFLRCTING ENDOBRONCHIAL BLOCKER

FDA 510(k)
FDA Class 2 ·Anesthesiology

NO CODE AVAILABLE

FDA Adverse Event
Injury ·SYNTHES USA·Product code GXN·March 8, 2016

SYNCARDIA CARDIOWEST

FDA Adverse Event
Injury ·SYNCARDIA SYSTEMS, INC.·Product code DSQ·April 3, 2013

UNKNOWN DEPUY LINER

FDA Adverse Event
Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·March 17, 2011

MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

FDA Adverse Event
Injury ·MEDTRONIC HEART VALVES, INC·Product code LWR·April 24, 2008

PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

FDA Adverse Event
Injury ·SYNTHES USA·Product code GWO·June 21, 2016

Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022

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

Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

FDA Enforcement
Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013