22 results
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42ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VACUETTE TRACE ELEMENTS TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
BD VACUTAINER SAFETY COAGULATION TUBE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES HAGENDORF·Product code KTT·August 27, 2015
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code HWC·September 23, 2015
BD VACUTAINER® PLUS CITRATE TUBE 2.7ML WITH LIGHT BLUE HEMOGARD CLOSURE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 5, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 1, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 6, 2017
BD VACUTAINER® CITRATE TUBES 4.5 13X75 NA CITRATE (0.105M = 3.2%)
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 10, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 14, 2017
BD VACUTAINER® PLUS CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 8, 2017
CITRATE TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 27, 2017
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·March 27, 2013
GOBED II
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·February 14, 2011
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP.
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 4, 2008
APPLIANCE, FIXATION, NAIL
FDA Adverse Event
Injury
·SYNTHES USA·Product code KTT·August 18, 2015
BD VACUTAINER® BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·May 24, 2019
APPLIANCE,FIXATION,NAIL
FDA Adverse Event
Injury
·SYNTHES BETTLACH·Product code KTT·October 10, 2016
UNSPECIFIED BD BLOOD COLLECTION TUBE
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (BROKEN BOW)·Product code JKA·June 19, 2019
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021