13 results
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23ms
·
Sources: EU EUDAMED, US FDA
WAKO L-TYPE GLUCOSE 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GARD FILTER, COMBIGARD FILTE / HME
FDA 510(k)
FDA Class 2
·Anesthesiology
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·March 27, 2013
ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code HQL·March 18, 2011
G2 FILTER SYSTEM - FEMORAL
FDA Adverse Event
Malfunction
·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·March 27, 2008
INDIGO SYSTEM CAT RX ASPIRATION CATHETER
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code QEX·December 27, 2019
VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAM·October 22, 2024
SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAK·October 22, 2024
SUTURE UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAK·October 22, 2024
PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAW·October 22, 2024
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
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