16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3
FDA 510(k)
FDA Class 2
·Radiology
Ceramco® II Silver™
FDA UDI
Dentsply International Inc.·D0011612240·
creos™ syntoprotect
FDA UDI
Nobel Biocare AB·07332747181869·creos™ syntoprotect PTFE membrane 200 12 x 24 m...
Symmetry Rochester Ochsner
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482039878·Symmetry® Forceps, Rochester Ochsner, Straight,...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071150389·16F x 1.2cm MiniSPC Low Profile Suprapubic Cath...
MiniSPC Button
FDA UDI
APPLIED MEDICAL TECHNOLOGY, INC.·00842071147761·16F x 1.2cm MiniSPC Low Profile Suprapubic Cath...
SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
FDA 510(k)
FDA Class 2
·General Hospital
LAPDOC I
FDA 510(k)
FDA Class 2
·Neurology
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 13, 2011
COLLEAGUE VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 17, 2008
Artis zeego, Model Number 10280959
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022
Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·October 21, 2020
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 Product Usage: Artis is a family of 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·March 25, 2020
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
FDA Enforcement
Class II
·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023
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