16 results
·
27ms
·
Sources: EU EUDAMED, US FDA
POLLER CALIBRANTS
FDA 510(k)
FDA Class 2
·Hematology
Monolith
FDA UDI
Nuvasive, Inc.·00887517677297·Monolith Core, Ø14x39mm
HEAD FIXATION ARC AND TABLE BASE
FDA 510(k)
FDA Class 2
·Neurology
OverStitch 2-0 Polypropylene Suture
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CDS/R/4K DILUENT/SHEATH, 20L
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·April 12, 2007
CD SAPPHIRE, CD 4000 SYSTEMS DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIV/CELLDYN·Product code GKL·December 8, 2006
ZEPHIR ANTERIOR CERVICAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC INC.·Product code KWQ·June 11, 2009
CELL-DYN DILUENT/SHEATH
FDA Adverse Event
Malfunction
·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKL·January 5, 2007
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Death
·RICE CREEK MFG·Product code DTB·March 6, 2013
RENAL - DISPOSABLE
FDA Adverse Event
Product code KDJ·February 15, 2011
SELECTSECURE
FDA Adverse Event
Injury
·MPRI·Product code NVN·August 8, 2014
Daig Livewire Steerable, Product Number 401581; REPROCESSED ELECTROPHYSIOLOGY CATHETER
FDA Enforcement
Class II
·Ongoing·Stryker Sustainability Solutions·May 20, 2026
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Enforcement
Class II
·Terminated·Terumo BCT, Inc.·November 22, 2017
HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017
HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO
FDA Recall
Terminated
·Terumo BCT, Inc.·Product code JQC·October 20, 2017