12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN
FDA 510(k)
FDA Class 2
·Microbiology
Baltic Denture System BD Load
FDA UDI
Merz Dental GmbH·D7091032738·Baltic Denture System BDLoad Ln6 PLSEbil2DFl BL...
BAYER RAPIDPOINT 400 SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLEXI-SEAL FMS
FDA Adverse Event
Other
·CONVATEC·Product code KNT·June 7, 2006
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·April 3, 2013
SET, A.V. FISTULA NEEDLE, WING EATER SAFETY 15 G. JMS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code FIE·February 18, 2011
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·August 25, 2014
FLEXI-SEAL FECAL MANAGEMENT SYSTEM
FDA Adverse Event
Malfunction
·CONVATEC INC.·Product code KNT·October 20, 2016
The Spirit Plus Bed, Model 5600 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018
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