12 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CERADRILL
FDA 510(k)
FDA Class 1
·Dental
INTREX
FDA UDI
Conmed Corporation·10845854010280·INTREX LARGE BONE OSCILLATING SAW BLADE 13.0 X ...
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
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·August 8, 2014
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 22, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 9, 2014
ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·July 8, 2008
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