9 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TRANS1 FACET SCREWS
FDA 510(k)
FDA Unclassified
·Unknown
ACUMATCH GXL 15DEG LINER 36MM SZ J
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·April 19, 2024
RADIOGRAPHIC MARKERS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SUPERCROSS CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
INSYNC II MARQUIS
FDA Adverse Event
Injury
·IPG MFG SWITZERLAND·Product code NIK·April 10, 2013
FINELINE II
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVN·April 12, 2011
DLP PERICARDIAL/INTRACARDIAC SUMPS
FDA Adverse Event
Injury
·MEDTRONIC PERFUSION SYSTEMS·Product code DWF·May 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
Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018