14 results
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19ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DIGNITY POWER INJECTABLE TITANIUM PORT
FDA 510(k)
FDA Class 2
·General Hospital
OR Head Holder LUCY with HeadCoilSet Philips 1.5T
FDA UDI
Noras MRI products GmbH·04251269205811·The NORAS OR Head Holder LUCY is used for intra...
OR Head Holder LUCY with HeadCoilSet Philips 1.5T
FDA UDI
Noras MRI products GmbH·04251269207303·The intended medical use of the OR Head Holder ...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033497·Cottle Nasal Scissors
straig...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033473·Beuse Nasal Scissors
slight...
RZ Medizintechnik GmbH
FDA UDI
RZ-Medizintechnik GmbH·04049197033480·Beuse Nasal Scissors
slight...
THERMAL MASSAGE BED, MODEL 2D-GX
FDA 510(k)
FDA Class 2
·Physical Medicine
MODIFICATION TO VENTLAB HYPERINFLATION BAG SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
UNKNOWN PRODUCT - SET SCREW
FDA Adverse Event
Injury
·STRYKER OSTEOSYNTHESIS KIEL·Product code HWC·October 12, 2012
OSSIX BONE, OSSIX PLUS
FDA Adverse Event
Injury
·DATUM DENTAL LTD.·Product code NPM·June 22, 2022
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·May 20, 2013
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 26, 2014
TRANSSEPTAL NEEDLE, BRK 1, 71CM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, AF DIVISION·Product code DRC·June 7, 2011
Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for decay using digital radiographs. -Initial radiographic assessment of inter-proximal caries (Presently limited to RVG 6100 & 6500 bitewing radiographs in horizontal format) Identify and direct attention to potential interproximal caries sites for possible restoration or other treatment (Focus for further investigation. PRESCAN NOT INTENDED TO BE FINAL ASSESSMENT.) Track interproximal decay progression over time Patient education tool
FDA Enforcement
Class II
·Terminated·GA Industries·May 6, 2015