13 results
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27ms
·
Sources: EU EUDAMED, US FDA
PENTAX ED-3490TK, VIDEO DUODENOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PENTAX
FDA Adverse Event
Injury
·HOYA CORP.·Product code FDT·July 24, 2015
Zavation
FDA UDI
Zavation LLC·00842166146310·eZspand PLIF/T-PLIF 9x27x10°, 8.5-13mm
Zavation
FDA UDI
Zavation LLC·00842166146167·eZspand PLIF/T-PLIF 9x27x10°, 7-11.5mm
Zavation
FDA UDI
Zavation LLC·00842166146464·eZspand PLIF/T-PLIF 9x27x10°, 10.5-15mm
DISPOSABLE POWDERED VINYL EXAMINATION GLOVES
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION)
FDA 510(k)
FDA Class 2
·Orthopedic
M2A-MAGNUM MOD HD SZ 52MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JDI·March 26, 2018
VERCISE GENUS?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code NHL·May 5, 2025
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - TURKEY·Product code FPA·May 3, 2013
HEARTSTART MRX
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·September 8, 2014
GREENLIGHT ADDSTAT
FDA Adverse Event
Malfunction
·AMERICAN MEDICAL SYSTEMS, INNOVATION CENTER - SILICON VALLEY·Product code GEX·May 2, 2011
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