17 results
·
26ms
·
Sources: EU EUDAMED, US FDA
Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)
FDA 510(k)
FDA Class 2
·General Hospital
4251676
FDA Adverse Event
Injury
·October 15, 2014
Retracta Detachable Embolization Coil
FDA 510(k)
FDA Class 2
·Cardiovascular
SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES
FDA 510(k)
FDA Class 2
·Neurology
KRD DEVICE, EMBOLIZATION, VASCULAR
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 19, 2019
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 16, 2011
PREFYX PPS® SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SPENCER·Product code FTL·July 29, 2013
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·June 20, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·September 17, 2018
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 2, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·January 2, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·March 11, 2020
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·July 31, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Injury
·COOK INC·Product code KRD·February 25, 2019
RETRACTA DETACHABLE EMBOLIZATION COIL
FDA Adverse Event
Malfunction
·COOK INC·Product code KRD·February 3, 2020
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024