11 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DIGITAL IMAGE SCANNER, MODEL DIS-1000
FDA 510(k)
FDA Class 2
·Radiology
OnBrace Crown UL4 w/ AWT (5/pk)
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199014230·
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083010690·Fixed, 4 electrode, CS, 10mm electrode spacing
PROFEMUR HIP SYSTEM MODULAR NECKS
FDA 510(k)
FDA Class 3
·Orthopedic
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
FDA 510(k)
FDA Class 2
·General Hospital
UNK
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·June 13, 2014
CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø 56
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·December 14, 2021
INTRALASE FS2
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code HNO·June 30, 2014
AVALON ELITE
FDA Adverse Event
Injury
·AVALON LABORATORIES LLC·Product code DWF·October 29, 2010
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·January 3, 2013
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