12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CARRIGEN
FDA 510(k)
FDA Class 2
·Orthopedic
ISOBAR SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PROTRACT PRESS FIT HIP STEM
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 21, 2025
CROSS PLATE MTP, RIGHT ANCHORAGE
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·November 27, 2024
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·April 26, 2013
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2014
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 18, 2011
CROSS PLATE MTP, RIGHT ANCHORAGE
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·November 25, 2024
CROSS PLATE MTP, RIGHT ANCHORAGE
FDA Adverse Event
Injury
·STRYKER GMBH·Product code HRS·November 21, 2024
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·December 28, 2016
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