11 results · 21ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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