13 results
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20ms
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Sources: EU EUDAMED, US FDA
SONOLINE ANTARES WITH CLARIFY VE
FDA 510(k)
FDA Class 2
·Radiology
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033196·Baltic Denture System BDLoad BDLoad Mm6 PLSEbi...
ASCEND SPINAL FIXATION SYSTEM WITH THE SHADOW SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHRON SYSTEMS AMMONIA REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MARKERS
FDA Adverse Event
Malfunction
·PRAXIM·Product code HAW·January 3, 2007
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
HOURGLASS
FDA Adverse Event
Injury
·MEDTRONIC·Product code MQP·June 16, 2014
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·April 3, 2013
POWER PRO AMBULANCE COT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code INK·February 28, 2011
REVOLUTION CATHETER
FDA Adverse Event
Other
·VOLCANO CORPORATION·Product code DQO·April 23, 2008
UNKNOWN
FDA Adverse Event
Malfunction
·COOK INC·Product code BWC·September 4, 2019
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
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD Inc.·April 24, 2024