19 results
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19ms
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Sources: EU EUDAMED, US FDA
MAGTARAK RESPIRATORY MONITOR & FLOW SENS
FDA 510(k)
FDA Class 2
·Anesthesiology
SLPSS
FDA UDI
SPINAL ELEMENTS·00840916118037·SLPSS Straight Rod, 55mm
SLPSS
FDA UDI
SPINAL ELEMENTS·00840916118020·SLPSS Curved Rod, 55mm
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575200818·5 hole flanges,with caudal flange
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 18, 2026
KANGAROO
FDA Adverse Event
Injury
·CARDINAL HEALTH 200, LLC·Product code KNT·April 6, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·April 17, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·May 1, 2026
CATGUT CHROM 1 (5) 90CM HR37S
FDA Adverse Event
Malfunction
·B. BRAUN SURGICAL S.A.·Product code GAM·February 28, 2014
TRANSTAR STRETCHER
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FPO·October 8, 2012
MOSAIC
FDA Adverse Event
Malfunction
·MEDTRONIC·Product code LWR·August 24, 2010
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·February 5, 2026
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·December 30, 2024
KANGAROO
FDA Adverse Event
Malfunction
·CARDINAL HEALTH 200, LLC·Product code KNT·November 25, 2025
Pipeline Flex Embolization Device
FDA Enforcement
Class I
·Ongoing·Micro Therapeutics Inc,·September 15, 2021
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048 121711052 121712050 121712052 121712056 121722048 121722050 121722052 121722054 121722056 121722058 121722060 121722062 121731048 121731050 121731052 121731054 121731056 121731058 121731060 121731062 121732048 121732050 121732052 121732054 121732056 121732058 121732060 121732062 121732064 - Product Usage: The PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·January 13, 2021
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012