13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Xenograft Bovine Bone Particulate
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257127964·30-40 MV FOR MEN SEL CALF STD TAN III
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257125786·30-40 MV FOR MEN CLSC CALF STD TAN III
Holder, Needle, TC, acc. Mayo-Hegar 24cm
FDA UDI
Geister Medizintechnik GmbH·04057034064429·Holder, Needle, TC, acc. Mayo-Hegar
24cm ...
URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE
FDA 510(k)
FDA Class 2
·Clinical Toxicology
INFUSET FLOW CONTROL EXTENSION SET
FDA 510(k)
FDA Class 2
·General Hospital
IMPLANT, ENDOSSEOUS, ROOT-FORM
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 28, 2025
TANDEM T: SLIM INSULIN DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE INC.·Product code LZG·November 4, 2014
ISOFLEX LEAD
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·September 9, 2011
INCEPTA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 22, 2013
CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)
FDA Adverse Event
Death
·CURRENT HEALTH LTD·Product code MSX·September 9, 2024
Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024