8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
Printed Lower ROC Pack for Herbst LR4 10mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015550·
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GYNECARE MESH UNKNOWN
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTO·June 30, 2014
RUSCH FLEXI-SLIP STYLET 14 FR, 45CM
FDA Adverse Event
Malfunction
·TELEFLEX·Product code BSR·January 4, 2013
ALARIS SE PUMP AMINISTRATION SET
FDA Adverse Event
Malfunction
·CAREFUSION CORP.·Product code FPA·November 10, 2010
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