20 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIFE+CEL OR LIFECEL BATTERY
FDA 510(k)
FDA Class 3
·Cardiovascular
Cook
FDA UDI
COOK INCORPORATED·00827002141902·Fascial/Urethral Dilator
SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
FDA 510(k)
FDA Class 2
·General Hospital
CONFORMANCE CHEMISTRY CONTROL C3
FDA 510(k)
FDA Class 1
·Clinical Chemistry
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 11, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 3, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 23, 2025
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·November 27, 2024
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·March 31, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·April 23, 2013
LEAD MODEL 302
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code LYJ·April 13, 2011
MULTI-LINK RX VISION CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·July 1, 2008
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD.·Product code BTT·February 15, 2010
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 12, 2024
RESPIRATORY HUMIDIFIER
FDA Adverse Event
Injury
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·July 4, 2024
8015 ALARIS SYSTEM PC UNIT
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·December 22, 2020
LOCKING SCREW, FULLY THREADED S2 Ø5X40 MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA KIEL·Product code HSB·April 24, 2017
880 HUMIDIFICATION SYSTEM
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·April 15, 2010
FISHER & PAYKEL HEALTHCARE
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 6, 2023
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