10 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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IMNI HOT PACKS
FDA 510(k)
FDA Class 1
·Physical Medicine
MIS ELECTROSURGICAL ELECTRODES
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
INFUSION DEVICES - UNKNOWN
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·August 30, 2024
G7 ACETABULAR LINER
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code PBI·April 6, 2018
G7 ACETABULAR LINER
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code PBI·August 7, 2017
CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT
FDA Adverse Event
Malfunction
·INTEGRA NEUROSCIENCES, LTD.·Product code GWM·June 25, 2014
BECKMAN COULTER AU2700 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JGS·February 11, 2013
TENDRIL STS
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 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