11 results · 19ms · Sources: EU EUDAMED, US FDA

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HEMOSIL PT-FIBRINOGEN HS PLUS

FDA 510(k)
FDA Class 2 ·Hematology

Mini-Sprint®

FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609311·Mini Sprint-Brackets Roth .022" 20 Brackets 3 w...

BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA

FDA Adverse Event
Malfunction ·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·July 8, 2019

AMS SACRAL COLPOPEXY SLING, MODEL 72403501

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

AU5 ULTRASOUND IMAGING SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

TIGER SPINE SYSTEM

FDA Adverse Event
Malfunction ·CORELINK, LLC.·Product code MNH·April 10, 2013

RESTORE PRIME ADVANCED

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 14, 2011

HEMOLOK LIGATING CLIP

FDA Adverse Event
Other ·TELEFLEX MEDICAL·Product code GDO·June 12, 2008

BIODESIGN URETHRAL SLING

FDA Adverse Event
Injury ·COOK BIOTECH·Product code FTM·July 29, 2013

Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011

Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy X-ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

FDA Recall
Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011