18 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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syngo.via MI Workflows
FDA 510(k)
FDA Class 2
·Radiology
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613084875·K-Wire, Double Ended, Trocar Point, Diameter 0....
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197059985·Nasal applicator
Ø1.1mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197059978·Farrell Cotton Applicator
Ø 0,9m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197060011·FARREL cotton appl. triangular
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197059954·Farrell Cotton Applicator
Ø 0,9m...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197383349·Farrell applicator
Ø1.2mm...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197060004·Farrell Cotton Applicator
Ø1,2mm...
DYNA-EXTOR II
FDA 510(k)
FDA Class 2
·Orthopedic
LIBERTY GLUCOSE NORMAL CONTROL SOLUTIONS, MODEL 2120041
FDA 510(k)
FDA Class 1
·Clinical Chemistry
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 20, 2022
O3 PEDIATRIC SENSOR
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code MUD·August 19, 2022
GORE® TAG® THORACIC ENDOPROSTHESIS
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code MIH·September 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MPRI·Product code DTB·June 10, 2013
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·June 20, 2011
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·September 16, 2008
ROOT
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code MWI·September 20, 2018
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·December 28, 2016