19 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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HEART SYNC PEDIATRIC, MODEL PED-100
FDA 510(k)
FDA Class 2
·Cardiovascular
ESU HANDSWITCHING PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ABBOTT PLUM A+INFUSION PUMP, MODEL 11971
FDA 510(k)
FDA Class 2
·General Hospital
SPECTRA WAVEWRITER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 8, 2021
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code MGB·November 14, 2025
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 9, 2014
ACTIVA PC
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·April 22, 2011
RX WALLSTENT BILIARY ENDOPROSTHESIS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code FGE·July 25, 2008
Femoral Nail, A/R T2 Femur ¿10x320 mm, Product Number 18251032S
FDA Enforcement
Class II
·Terminated·Stryker GmbH·July 18, 2018
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 21, 2026
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 21, 2026
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·January 21, 2026
BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 10, 2024
BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 10, 2024
BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 10, 2024
BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 9, 2024
BD SAF-T-INTIMA Y ADP BL 22GA X 0.75IN ROW
FDA Adverse Event
Malfunction
·BD SUZHOU (MDS)·Product code FOZ·December 9, 2024
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
Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.
FDA Enforcement
Class I
·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024