16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Remington Medical, Inc. Automatic Cutting Needle (NAC)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Bernafon
FDA UDI
Bernafon AG·05711584086025·ZR3 B 105, 2.4G NFM DPB MAC ZERENA 3
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK113151·DD tempMED are pre-colored dental milling blank...
COVIDIEN EXTENDED TIP APPLICATOR
FDA 510(k)
FDA Class 2
·General Hospital
MULTIPURPOSE DRAINAGE CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·May 19, 2026
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·September 24, 2025
ACQUIRE? PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·October 10, 2025
EXPECT PULMONARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EOQ·November 14, 2024
EXPECT PULMONARY
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·April 14, 2026
HARMONIC ACE 36 CM
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code LFL·October 9, 2008
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS INC·Product code MUZ·July 27, 2011
VITROS 5,1 FS CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·ORTHO-CLINICAL DIAGNOSTICS·Product code JJE·June 26, 2013
dS Breast 7ch 1.5T
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 4, 2024
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems·October 10, 2018
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