12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
FDA 510(k)
FDA Class 2
·Ophthalmic
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300231·Mand. 1. Molar band W-Fit right 23
NeoGen
FDA UDI
ENERGIST LIMITED·05060440520334·Grey trolley (new logo)
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300230501·Mand. 1. Molar band W-Fit right 23
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300230051·Mand. 1. Molar band W-Fit right 23
N.A.
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR89300230101·Mand. 1. Molar band W-Fit right 23
ART-Plan
FDA 510(k)
FDA Class 2
·Radiology
K100 NEUTRAL DISPLACEMENT NEEDLE FREE CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
PFC SIGMARP CV TB/IN S3 12.5
FDA Adverse Event
Injury
·DEPUY (IRELAND)·Product code NJL·January 25, 2013
7700
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·December 2, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 11, 2014
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS45; c) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS50; d) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS55; e) PEDIATRIC TRACHEOSTOMY TUBE 6.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS60
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024