12 results
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18ms
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Sources: EU EUDAMED, US FDA
GOLDWAY UT4000A VITAL SIGNS MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
Baltic Denture System BDLoad
FDA UDI
Merz Dental GmbH·D7091033988·Baltic Denture System BDLoad BDLoad Mw7 PLSEbi...
MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
FDA 510(k)
FDA Class 2
·Anesthesiology
UROSCOPE, ARTES MEDICAL, USA
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAD-5V HANDHELD
FDA Adverse Event
Malfunction
·MASIMO CORPORATION·Product code DQA·July 10, 2015
RAD-5 PULSE OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·July 13, 2018
8100 ALARIS PUMP MODULE
FDA Adverse Event
Malfunction
·CAREFUSION SD·Product code FRN·November 24, 2020
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·April 3, 2013
GLOBAL ADVANTAGE STEM 14 MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code KWS·March 17, 2011
ACCU-CHEK COMFORT CURVE TEST STRIPS
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code LFR·April 25, 2008
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