14 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AMPLATZER VASCULAR PLUG II MODELS: AVP2-004, AVP2-006, AVP2-008, AVP2-010, AVP2-012, AVP2-014, AVP2-016
FDA 510(k)
FDA Class 2
·Cardiovascular
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201749·
CONMED
FDA UDI
Conmed Corporation·10845854000298·OSCILLATOR BLADE, 50 X 19 X 0.4 MM (.016 IN.)
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201060·
NA
FDA UDI
STERILMED, INC.·10888551020374·SAW BLADE REPEAT STERNOTOMY
KOMET Surgical Saw Blade
FDA UDI
Gebr. Brasseler GmbH & Co. KG·14053613201763·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16710030711250·
NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
FDA 510(k)
FDA Class 1
·Anesthesiology
GEUDER INJECTOR FOR MORCHER CAPSULAR TENSION RING
FDA 510(k)
FDA Class 1
·Ophthalmic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 23, 2026
PREFYX PPS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·April 22, 2013
ARCHITECT IVANCOMYCIN
FDA Adverse Event
Malfunction
·ABBOTT GERMANY·Product code LEH·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 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