12 results
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22ms
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Sources: EU EUDAMED, US FDA
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Brigade
FDA UDI
Nuvasive, Inc.·00887517961297·Brigade Lateral Trial, 12x34x24mm 10°
SwishPlant® Implant
FDA UDI
IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307105855·3.3mmD x 16mmL, 3.7mmD Platform
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515228795·Curette, dbl end, cups lightly ang, 2.0mm and 2...
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450204979·
FLOWREST
FDA 510(k)
FDA Class 2
·Anesthesiology
OTI CERAMIC FEMORAL HEAD SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·June 30, 2014
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 12, 2010
MACROLYTE INFANT DISPERSIVE ELECTRODE
FDA Adverse Event
CONMED·Product code GEI·December 26, 2012
COMBINATION BENDING/CUTTING PLIERS F/1.0MM - 2.0MM PLATES
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTC·March 8, 2017
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