21 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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OPI BAND
FDA 510(k)
FDA Class 2
·Neurology
artVeneer life
FDA UDI
Merz Dental GmbH·D7092001167·artVeneer life upper anteriors, CS, B1
DADE BEHRING COAGULATION ANALYZER (BCT)
FDA 510(k)
FDA Class 2
·Hematology
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HAMILTON-C1
FDA Adverse Event
Malfunction
·HAMILTON MEDICAL AG·Product code CBK·January 24, 2025
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·December 29, 2022
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·February 8, 2022
CARDIOSAVE HYBRID TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·February 14, 2022
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·February 26, 2013
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code JJE·February 24, 2011
ASCENSIA CONTOUR
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·February 15, 2008
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·October 10, 2025
CARDIOSAVE HYBRID, TYPE B PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP. - MAHWAH·Product code DSP·December 28, 2022
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·June 25, 2007
CYPER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·June 25, 2007
CARDIOSAVE HYBRID, TYPE G PLUG
FDA Adverse Event
Malfunction
·DATASCOPE CORP.·Product code DSP·December 28, 2023
ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·February 5, 2014
Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
FDA Enforcement
Class II
·Terminated·Natus Medical Incorporated·December 21, 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
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. 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