12 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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VICROSAFE 6 AND VICROSAFE 12
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LEONE SPA
FDA UDI
LEONE SPA·08033707086703·BANDE ANATOMICHE SMILE I MOL UL 41
Obtura Spartan
FDA UDI
OBTURA SPARTAN ENDODONTICS·00816168020299·Tip BUC-1
Obtura Spartan
FDA UDI
Young Innovations, Inc.·00843471100523·Tip BUC-1
BOSS Instruments
FDA UDI
BOSS INSTRUMENTS, LTD., INC.·00888515236530·Swiss Osteotome, 13cm, 5 1/8", 8mm edge, cvd
COBAS B 101 HBA1C TEST
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LCP·October 3, 2019
SHEATHES STERILE ULTRASOUND GEL
FDA 510(k)
FDA Class 2
·Radiology
Spectrum IQ Infusion System with Dose IQ Safety Software
FDA 510(k)
FDA Class 2
·General Hospital
SECURE 3 MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 25, 2013
INTERSTIM
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·November 18, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 11, 2014
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