17 results
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22ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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SOLAR REUNION FRACTURE STEM
FDA 510(k)
FDA Class 2
·Orthopedic
CTXA Hip Bone Mineral Densitometer
FDA UDI
MINDWAYS SOFTWARE, INC.·B052DICTXAHIP0·The CTXA Hip Bone Mineral Densitometer (CTXA Hi...
Universal Precision Composite Instrument #3 (UPC3)
FDA UDI
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.·07540172012805·Dental restorative material applicator
Symmetry Adson
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482052143·Symmetry® Forceps, Adson Tissue, Serrated, 1x2 ...
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004309·Rumor .018 LL3 -6T 3A 0O
Rumor
FDA UDI
Ortho Organizers, Inc.·00190707004316·Rumor .018 LL3 HK -6T 3A 0O
CTXA HIP; CTXA; QCT PRO CTXA HIP
FDA 510(k)
FDA Class 2
·Radiology
INDWELLING FECAL MANAGEMENT SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HNM MEDICAL
FDA UDI
HNM STAINLESS, LLC.·00842962162972·ADSON TISSUE FORCEPS 1X2 SERRATED
VERTE-STACK® SPINAL SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH·Product code MQP·October 7, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·April 16, 2013
8800
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE, LTD.·Product code JAA·April 6, 2011
SYNCHROMED
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 18, 2008
CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD, Inc.·June 24, 2015
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022