14 results
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18ms
·
Sources: EU EUDAMED, US FDA
ANGIOTEC IMAGE MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 1
·Radiology
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083017026·STR, 4 electrode, MPD-CS-M, 2mm electrode spacing
Sklar®
FDA UDI
SKLAR CORPORATION·10649111230073·LASER GRAVES SPEC MED W/O TB
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515230057·Delacki Chisel, sltly ang 20deg,nrrw edge,.5mm wid
MYKNEE CUTTING BLOCKS
FDA 510(k)
FDA Class 2
·Orthopedic
URETEROSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 12, 2020
EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 12, 2020
EXT SET 17IN MACRO 0.2 M-FLTR CLV-Y SL
FDA Adverse Event
Malfunction
·ICU MEDICAL COSTA RICA LTD.·Product code FPA·February 12, 2020
MEDACTA KNEE IMPLANTS
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·January 28, 2016
CORE SUMEX DRILL
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code ERL·June 30, 2014
OXIMAX N-595 PULSE OXIMETER
FDA Adverse Event
Malfunction
·COVIDIEN·Product code DPZ·January 2, 2013
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code NIQ·November 20, 2010
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