11 results
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18ms
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Sources: EU EUDAMED, US FDA
MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
CONMED
FDA UDI
Conmed Corporation·10845854000335·OSCILLATOR BLADE. 19.5 X 80 X 0.8 MM (.031")
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
FDA 510(k)
FDA Class 2
·Microbiology
GE LOGIQ 9, MODEL 2188900-X
FDA 510(k)
FDA Class 2
·Radiology
GRAFTON DBM
FDA Adverse Event
Injury
·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019
TI COLLAR WITH GROOVES
FDA Adverse Event
Malfunction
·SYNTHES BRANDYWINE·Product code MNI·April 22, 2013
CIDEX ACTIVATED DIALDEHYDE SOLUTION
FDA Adverse Event
Injury
·ADVANCED STERILIZATION PRODUCTS·Product code LRJ·April 27, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 10, 2008
BD TEXIUM¿ NEEDLE-FREE SYRINGE
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022
ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
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