16 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AEVUMED PHANTOM Suture Anchors
FDA 510(k)
FDA Class 2
·Orthopedic
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304555266·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868240102·
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
FDA 510(k)
FDA Class 2
·Immunology
INNESIS PEEK CAGE
FDA 510(k)
FDA Class 2
·Orthopedic
RESOLUTE INTEGRITY RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·January 8, 2019
ENDEAVOR RX
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code NIQ·January 8, 2019
Y-KNOT ALL SUTURE ANCHOR
FDA Adverse Event
Injury
·CONMED LINVATEC·Product code MBI·June 20, 2013
MITEK NON ABSORBABLE ANCHOR IMPLANT
FDA Adverse Event
Injury
·DEPUY MITEK·Product code JDR·July 27, 2011
SJM EPIC STENTED TISSUE VALVE
FDA Adverse Event
Injury
·ST JUDE MEDICAL BRASIL LTD.·Product code LWR·September 26, 2008
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2022
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2022
BINAXNOW COVID-19 ANTIGEN SELF-TEST
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 22, 2022
Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·September 7, 2022
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)
FDA Enforcement
Class II
·Ongoing·Medtronic Inc.·November 29, 2017
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024