17 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05
FDA 510(k)
FDA Class 2
·Cardiovascular
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450619933·
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450409183·
BD LUER-LOK TIP SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·September 8, 2021
MALLINCKRODT
FDA Adverse Event
Injury
·COVIDIEN·Product code BTR·February 26, 2014
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
FDA 510(k)
FDA Class 2
·Cardiovascular
REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
FDA 510(k)
FDA Class 2
·Immunology
BD MEDICAL (BD WEST) MEDICAL SURGICAL
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·June 24, 2021
TENDRIL STS
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 14, 2014
PANORAMA CENTRAL STATION
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·May 17, 2011
SYRINGE 50ML LL TIP 1ML
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·July 28, 2021
ARROW AGBA PICC NAVICURVE: 3L 6FR X 55CM BP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·April 23, 2025
ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·August 5, 2025
ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM TCG
FDA Adverse Event
Malfunction
·ARROW INTERNATIONAL LLC·Product code LJS·January 16, 2025
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