11 results
·
29ms
·
Sources: EU EUDAMED, US FDA
ADULT-PED WET W/PRE-ATTACHED ATS BAG
FDA Adverse Event
Death
·DEKNATEL, INC.·Product code KDQ·August 5, 1997
PLEUR-EVAC AUTOTRANSFUSION SYSTEM
FDA Adverse Event
Death
·DEKNATEL, INC.·Product code CAC·November 17, 1995
PLEUR-EVAC PLUS CHEST TUBE DRAIN
FDA Adverse Event
Malfunction
·DEKNATEL, INC.·Product code KDQ·August 11, 1995
PLEUR-EVAC INFANT SINGLE COLLECTION W/DRY SUCTION
FDA Adverse Event
Injury
·DEKNATEL, INC.·Product code KDQ·January 8, 1998
CARDIOTOMY RESERVOIR W/ DEPTH FILTER
FDA Adverse Event
Malfunction
·DEKNATEL, INC.·Product code DTN·December 10, 1997
PLEUR - EVAC A - 7000
FDA Adverse Event
Injury
·DE KNATEL INC.·August 31, 1993
PLEUREVAC
FDA Adverse Event
Malfunction
·DEKNATEL DIV. PFIZER HOSPITAL PRODUCTS GRP., INC.·Product code KDQ·June 27, 1994
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·May 14, 2014
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
FDA Recall
Terminated
·Teleflex Medical·Product code GAR·March 11, 2014
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
FDA Recall
Terminated
·Teleflex Medical·Product code GAQ·March 11, 2014
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
FDA Enforcement
Class II
·Terminated·Teleflex Medical·May 14, 2014