8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FLOWERS DORSAL COLUMELLA IMPLANT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
TRU® Prosthetic Screw RP .050" Hex, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549112874·TRU Prosthetic Screw RP .048" Hex. These Prost...
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
FDA 510(k)
FDA Class 2
·Cardiovascular
UNIVERSAL DELIVERY SYSTEM CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC·Product code KNS·May 23, 2014
EASYPUMP II LT 270-27-S
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL PRODUCTION LTD.·Product code MEB·January 4, 2013
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·November 22, 2010
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