11 results
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20ms
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Sources: EU EUDAMED, US FDA
5 IN 1 CONNECTOR
FDA 510(k)
FDA Class 2
·General Hospital
MMI/GAELTEC CATHETER TIP PRESS. TRANSDU
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and Reloads, Single Use Endoscopic Linear Cutters and Reloads, Single Use Hemorrhoidal Staplers, Single Use Linear Staplers and Reloads
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PRIMUS HI
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE GMBH·Product code IYE·May 29, 2020
VIVA XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 8, 2010
ALUMINUM BLUNT PELVIC RETRACTOR
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code GAD·December 7, 2012
PIPELINE FLEX
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 11, 2020
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012