9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PTI ANASTOMARK(TM) CORONARY BYPASS GRAFT MARKERS
FDA 510(k)
FDA Class 2
·Cardiovascular
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083012373·STR, 20 electrode, MPD-H, 5mm electrode spacing
MATTA - PELVIC
FDA UDI
Stryker GmbH·07613153057727·Tray Insert
VSCORE WITH EKG SIGNAL GATING
FDA 510(k)
FDA Class 2
·Radiology
LSVT C OR LSVT COMPANION, MODEL V.1
FDA 510(k)
FDA Unclassified
·Unknown
INFINITI VISION SYSTEM OZIL
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·May 7, 2014
LIFEVEST WCD 3000 SYSTEM
FDA Adverse Event
Malfunction
·ZOLL LIFECOR CORPORATION·Product code MVK·November 12, 2010
ALARIS PCA MODULE
FDA Adverse Event
Injury
·CAREFUSION CORPORATION·Product code FRN·January 2, 2013
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