9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Immunology
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
ADVIA CENTAUR CEA AND BR ASSAY
FDA Adverse Event
Other
·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code DHX·June 27, 2008
KerraContact Ag Perf Advanced Perforated Silver Wound Dressing
FDA 510(k)
FDA Unclassified
·Unknown
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
FDA 510(k)
FDA Class 2
·Clinical Chemistry
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 16, 2014
ARTHREX 5.5 MM CUTTER
FDA Adverse Event
Injury
·ARTHREX INC·Product code HRX·February 21, 2013
ARTELON CMC SPACER
FDA Adverse Event
Injury
·ARTIMPLANT AB·Product code KYI·February 2, 2011
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