14 results
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20ms
·
Sources: EU EUDAMED, US FDA
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
FDA 510(k)
FDA Class 2
·Anesthesiology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16740824550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674082455060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X0824550·8mm H x 24mm W x 55mm L x 0 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X082455120·8mm H x 24mm W x 55mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X08245580·8mm H x 24mm W x 55mm L x 8 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L082455120·8mm H x 24mm W x 55mm L XLIF Trial 12 degree Lo...
SPIFE LD-12 KIT, MODEL 3338
FDA 510(k)
FDA Class 2
·Clinical Chemistry
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, NEUROMODULATION·Product code LGW·April 16, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·May 10, 2011
ABC HIP
FDA Adverse Event
Malfunction
·STRYKER ORTHOPAEDICS MAHWAH·Product code JDI·July 22, 2008
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