16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3Shape Abutment Designer Software
FDA 510(k)
FDA Class 2
·Dental
CoRoent
FDA UDI
Nuvasive, Inc.·00887517232267·CoRoent XLW 15°, 14x22x55mm
OMNI Mod Hip
FDA UDI
Omni Life Science, Inc.·00841690102762·OMNI Modular Stem Size 5, 14.5mm
ProLift
FDA UDI
Life Spine, Inc.·00190837117559·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741514550·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674151455060·
ZB ProLift Narrow
FDA UDI
Life Spine, Inc.·00190837079291·
EKO 7 DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
WIESLAB CAP MPO-ANCA
FDA 510(k)
FDA Class 2
·Immunology
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962101834·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm...
HNM SPORTS MEDICINE
FDA UDI
HNM STAINLESS, LLC.·00842962104040·ETHOS PRO SMALL JOINT ANCHOR, PEEK, 2.9mm x 6mm...
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 8, 2014
EMPTY CONTAINER 100ML
FDA Adverse Event
Malfunction
·HOSPIRA, LTD·Product code KPE·May 30, 2013
TORNIER
FDA Adverse Event
Malfunction
·TORNIER, INC.·Product code KWS·June 8, 2011
COBAS AMPLIPREP / COBAS TAQMAN 48 ANALYZER
FDA Adverse Event
Malfunction
·ROCHE DIAGNSOTICS, LTD.·Product code JJF·October 4, 2010
IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.
FDA Enforcement
Class II
·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019