18 results · 21ms · Sources: EU EUDAMED, 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