13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
SENSITITRE 18 - 24 HOURS SUSCEPTIBILITY PLATES
FDA 510(k)
FDA Class 2
·Microbiology
ACCELERATOR RECIPROCATING CANNULA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·April 8, 2024
SPORT GRIP T25 STARDRIVE SHAFTF/MATRIX-LONG
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HXX·April 29, 2013
ASTRA TECH
FDA Adverse Event
Injury
·ASTRA·Product code DZE·May 5, 2011
SELOX ST 60
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO.·Product code DTB·July 23, 2008
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·July 25, 2025
REFLECTION CONSTRAINED ACETABULAR LINER
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code KWZ·June 8, 2025
Polyflex Esophageal Stent 20/16mm x 90mm
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ESW·April 16, 2003
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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