18 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SOLO-SAFE SAFETY SYRINGE, SIZE-3CC
FDA 510(k)
FDA Class 2
·General Hospital
SCI-PHARM POST SECURE
FDA 510(k)
FDA Class 2
·Dental
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 18, 2026
KANGAROO
FDA Adverse Event
Injury
·CARDINAL HEALTH 200, LLC·Product code KNT·April 6, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·April 17, 2026
SMR SHOULDER
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code KWT·July 9, 2025
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 1, 2026
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SWINFORD·Product code KDI·March 27, 2013
UNKNOWN DEPUY ASR FEMORAL HEAD
FDA Adverse Event
Malfunction
·DEPUY INTL LTD·Product code KWA·March 3, 2011
AXIALIF SYSTEM
FDA Adverse Event
Other
·TRANS1 INC·Product code JDN·March 28, 2008
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·December 30, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·November 25, 2025
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NPT·April 2, 2026
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
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018