26 results
·
33ms
·
Sources: EU EUDAMED, US FDA
FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300
FDA 510(k)
FDA Class 2
·Cardiovascular
PROGENY FORGED COCR CEMENTED FEMORAL COMPONENT
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET
FDA 510(k)
FDA Class 2
·General Hospital
KIT FLU A+B 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·December 9, 2021
KIT FLU A+B 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·December 9, 2021
KIT FLU A+B 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·December 9, 2021
KIT FLU A+B 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·December 9, 2021
KIT FLU A+B 30 TEST HOSPITAL VERITOR
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·December 9, 2021
BD KIT FLU A+B 30 TEST PHYSICIAN VERITOR
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PSZ·December 6, 2021
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·April 11, 2013
ONE TOUCH ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·May 22, 2008
FINE NEEDLE ELECTRODE
FDA Adverse Event
Malfunction
·COVIDIEN VALLEYLAB·Product code GEI·April 8, 2011
SPECIFIC DEVICE NOT REPORTED
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code KWS·February 22, 2024
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO., (BD)·Product code FMI·January 24, 2019
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code GTY·December 16, 2021
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code GTY·December 16, 2021
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code GTY·December 16, 2021
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code GTY·December 16, 2021
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code GTY·December 16, 2021
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