11 results
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21ms
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Sources: EU EUDAMED, US FDA
HEMOSTATIC SIDE-ARM ADAPTER
FDA 510(k)
FDA Class 2
·Cardiovascular
Bioplate®
FDA UDI
Bioplate, Inc.·M3848135780·X Plate - Ø1.5 mm - 6 hole - 17 mm (1), Self-Dr...
Bioplate®
FDA UDI
Bioplate, Inc.·M384813578US0·X Plate - Ø1.5 mm - 6 hole - 17 mm (1), Self-Dr...
PUMP TUBING
FDA 510(k)
FDA Class 2
·Cardiovascular
Torpedo Gelatin Foam
FDA 510(k)
FDA Class 2
·Cardiovascular
CER BIOLOXD OPTION HEAD 36MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LZO·May 15, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 25, 2010
RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·February 20, 2019
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corp·Product code DWF·May 22, 2007
Terumo TenderFlow Pediatric Arterial Cannulae, 5.3mm (16 Fr) OD, with 1/4 inch non-vented connector, 9 inch (22.9 cm) long; Catalog no. 813578. The TenderFlow (TM) Pediatric Arterial Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use.
FDA Recall
Terminated
·Terumo Cardiovascular Systems Corporation·Product code DWF·October 16, 2008