12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Tapered Pro Conical Implant System
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780455547·Integra® Jarit® Cobb Style Bone Curette, Hollow...
Oticon
FDA UDI
Sbo Hearing A/S·05714464053100·OTICON ZIRCON 1 MINIRITE R C063
RAY STATION
FDA 510(k)
FDA Class 2
·Radiology
MEDICINAL LEECHES
FDA 510(k)
FDA Unclassified
·Unknown
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 28, 2025
SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
FDA Adverse Event
Malfunction
·BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949·Product code FMF·March 15, 2024
SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
FDA Adverse Event
Malfunction
·EMBECTA MEDICAL I LLC - HOLDREGE, NE·Product code FMF·July 11, 2024
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 24, 2008
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JGS·September 9, 2011
RESTORE ADVANCED
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 22, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024