10 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
FDA 510(k)
FDA Class 2
·Cardiovascular
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496061052·MICROMASSAGE COMFORT, SIZE XL, NATUR, GRADUATED...
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70610521·Mini Sprint-Brackets 5-5 McLaugh/Benn/Trev. .02...
OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX
FDA 510(k)
FDA Class 2
·Radiology
MITEK OMNISPAN MENISCAL APPLIER
FDA Adverse Event
Injury
·DEPUY MITEK·Product code GEF·April 16, 2013
IMPACT
FDA Adverse Event
Other
·IMPACT INSTRUMENTATION, INC·Product code BTA·February 22, 2011
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FKX·June 12, 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
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015