16 results
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24ms
·
Sources: EU EUDAMED, US FDA
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Henry Schein
FDA UDI
HENRY SCHEIN, INC.·00304040067369·LOWER LEFT SINGLE BUCCAL TUBE,
LEONE SPA
FDA UDI
LEONE SPA·08033707065678·INTRAORAL ELASTICS 2,5 oz 3/8" orange
InTess Lumbar Cage
FDA UDI
Kalitec Direct LLC·B07312K0105020·Implant Inserter, 14-16mm, Sleeved
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2
MODEL THERMO TEK QUICKCARE
FDA 510(k)
FDA Class 2
·General Hospital
STEAM/EO RECORD CARD, MODEL CI 121
FDA 510(k)
FDA Class 2
·General Hospital
COSYCOT INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code FMT·January 21, 2016
BD VACUTAINER® URINE COLLECTION CUP
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code KDT·April 6, 2022
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·April 16, 2013
AU400 CLINICAL CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER MISHIMA K.K.·Product code JJE·April 18, 2011
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·June 11, 2008
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888123411, Size 14.5Fr/Ch (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD SPORT PACK Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888128461, Size 14.5Fr/Ch (4.85mm) x 28cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-cuffed Shaft and Heparin Coating, REF 8888145070, 14.5 FR/CH (4.85mm) x 28 cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008
PALINDROME EMERALD Kit - Cuffed Dual Lumen Catheter with Pre-curved Shaft and Heparin Coating, REF 8888145069, 14.5 Fr/CH (4.85mm) x 23cm. TYCO HEALTHCARE GROUP LP, Mansfield, MA 02048. --- NOTE: Both the "sport pack" and "kit" package configurations include the catheter, Venetrac insertion stylets, pull apart sheath, and other accessories necessary for placement. The kit includes additional components that would also be available at the hospital, such as a scalpel, wound dressing, etc. The Venetrac insertion stylet is an optional accessory. The 510k for the Venetrac accessory is K051584. The 510k for the catheter is K060509.
FDA Recall
Terminated
·Covidien·Product code NYU·September 19, 2008