11 results
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26ms
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Sources: EU EUDAMED, US FDA
RTM REHABILITATION TREADMILL, MODEL #945-200
FDA 510(k)
FDA Class 1
·Physical Medicine
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029045589·UP UNIV BI NO HK
Gnesis EMS Plus
FDA 510(k)
FDA Class 2
·Physical Medicine
BATTERY, RECHARGEABLE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
K-WIRE, RECON 3.2X400 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·June 29, 2011
Torcon NB Advantage Catheters - Product Usage: Intended for use in the peripheral and coronary vascular system, including the carotid arteries, in giographic procedures by physicians trained and experienced in angiographic techniques.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 27, 2019
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LGW·January 25, 2013
FEMORAL PLATE 15 HOLE RIGHT
FDA Adverse Event
Malfunction
·DEPUY ACE S.A. 'R.L.·Product code HRS·November 24, 2010
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code NIQ·July 11, 2014
Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015
Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014