14 results
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20ms
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Sources: EU EUDAMED, US FDA
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
FDA 510(k)
FDA Class 2
·Cardiovascular
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083018351·STR, 10 electrode, MPD-D, 5mm electrode spacing
Probes, Lacrimal
FDA UDI
KATENA PRODUCTS, INC.·00841668114353·LACRIMAL INTUBATION SET (BX/3)
UNKNOWN GLENOID
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·December 23, 2024
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118093011·DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, RIG...
DISTRACTION, INTERNAL
FDA UDI
KLS-Martin L.P.·00888118093004·DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, LEF...
EDGELOCK
FDA 510(k)
FDA Class 2
·Orthopedic
MP3000 SERIES II COMPACT VIDEO IMAGER
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN STEM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·January 17, 2025
UNKNOWN HUMERAL HEAD
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code PHX·January 17, 2025
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Injury
·ANIMAS CORPORATION·Product code LZG·June 30, 2014
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code NIQ·November 20, 2010
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 28, 2012
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