14 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
FDA 510(k)
FDA Class 2
·Cardiovascular
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221616000·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221616070·
TALOS° HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B1676221616150·
Symmetry Roux
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482059265·Symmetry® Retractor, Roux, 1 1/4 in Wide, 1 3/4...
DynaClip Quattro
FDA UDI
Medshape, Inc.·M9703000112216160·QUATTRO DYNACLIP STAPLE, 22X16X16
SyMRI
FDA 510(k)
FDA Class 2
·Radiology
DELIGHT DENTAL ER: YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 13, 2025
HNM Medical
FDA UDI
HNM STAINLESS, LLC.·00842962113875·ROUX RETRACTOR, 6 1/4", LARGE, DOUBLE ENDED, LONG
ENDO GIA UNIVERSAL 12MM SINGLE USE INST
FDA Adverse Event
Injury
·UNITED STATES SURGICAL·Product code GDW·August 19, 2011
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 3, 2014
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 11, 2013
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