11 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RESP-EZ(TM) RESPIRATORY MONITORING BELT
FDA 510(k)
FDA Class 2
·Anesthesiology
Nexxis
FDA UDI
Barco NV·05415334002180·MNA-440 ENC HDMI
Vitacrilic®
FDA UDI
FRICKE INTERNATIONAL, INC.·B7159033000·Cross Link Colorstable Self Curing Monomer
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·June 30, 2014
UNKNOWN DEPUY ASR HIP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code JDI·November 16, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·January 9, 2013
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Enforcement
Class II
·Ongoing·Barco N.V.·July 2, 2025
Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system
FDA Recall
Open, Classified
·Barco N.V. President Kennedypark 35 Kortrijk Belgium·Product code DXJ·May 9, 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