15 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PulseFlowDF
FDA 510(k)
FDA Class 2
·Cardiovascular
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04064984699588·GENUMEDI PSS BLUE, SIZE VI
TALOS® HA PEEK IBF
FDA UDI
MEDITECH SPINE, LLC·B167321508060·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B167311508060·
BD¿ STERILE CONVENIENCE TRAYS W/ 10ML LUER-LOK TIP SYRINGES
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·October 9, 2023
OPTECURE
FDA 510(k)
FDA Class 2
·Orthopedic
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PRODIGY AUTOCODE
FDA Adverse Event
Injury
·OK BIOTECH CO., LTD.·Product code NBW·March 10, 2016
PS TIBIAL INSERTS SZ 3, 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·May 1, 2023
DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·January 20, 2017
JOSTENT GRAFTMASTER
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MAF·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 6, 2011
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 9, 2008
Conmed System 5000 Electrosurgical unit, REF 60-8005-SYS, 60-8015-SYS, 60-8018-SYS, 60-8005-001, 60-8005-003, Conmed Corporation.
FDA Recall
Terminated
·Conmed Electrosurgery·Product code GEI·September 5, 2006
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