19 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05707131292100·ALTA2 PRO, BTE 13 WL 105 STG
Bard® Pediatric Urine Meter
FDA UDI
C. R. Bard, Inc.·00801741033124·Bard® Pediatric Urine Meter
RAUMEDIC- ICP-MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
NANOBLUTM 500
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 30, 2019
SNORERX
FDA Adverse Event
Injury
·APNEA SCIENCES·Product code LRK·May 22, 2017
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·June 8, 2013
TALENT STENT GRAFT WITH XCELERANT - HYDRO
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011
MBT CEM KEEL TIB TRAY SZ2
FDA Adverse Event
Injury
·DEPUY - CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·September 4, 2008
ActiveLife One-Piece Pre-Cut Closed End (ostomy) Pouch with skin barrier and filter 45mm (box of 60) 1 3/4 in. 45 mm
FDA Recall
Terminated
·ConvaTec·Product code LNO·July 31, 2006
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019
ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023
Artis zee biplane, Model Number 10094141
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 26, 2015
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012