15 results
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20ms
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Sources: EU EUDAMED, US FDA
KERR RESIN BONDED BRIDGE CEMENT
FDA 510(k)
FDA Class 2
·Dental
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780456650·Integra® Jarit® Obwegeser Retractor, 8-3/4", 60...
FILMARRAY GASTROINTESTINAL (GI) PANEL
FDA 510(k)
FDA Class 2
·Microbiology
QUICKELISA ANTHRAX-PA KIT
FDA 510(k)
FDA Class 2
·Microbiology
UniTip Catheter
FDA UDI
Unisensor AG·07640172973769·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971758·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971765·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971772·
UniTip Catheter
FDA UDI
Unisensor AG·07640172971789·
OT VERIO PRO PLUS METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 30, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·August 2, 2016
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·June 12, 2015
Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025
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
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026