11 results
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18ms
·
Sources: EU EUDAMED, US FDA
AUTOVAC CLOSED WOUND AUTOTRANSFUSION SYSTEM,7920 S
FDA 510(k)
FDA Class 2
·Anesthesiology
LEONE SPA
FDA UDI
LEONE SPA·08033707067191·LIGATURES MINI modules TRANSP/SILVER KIT
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123038·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 75mm
Woo More Play Coconut Love Oil
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PARIEFIX
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·January 28, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP·Product code FRN·February 1, 2014
COOL PATH CATHETER 7F, 1304-CP-7-25-L
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL, IRVINE·Product code OAD·November 30, 2010
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES USA·Product code HRS·August 6, 2014
OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012-44-XXXX; c. OPTETRAK Logic CR Tibial Inserts, Product Line 02-012-47-XXXX; d. OPTETRAK Logic CR Slope + Tibial Inserts, Product Line 02-012-48-XXXX; e. OPTETRAK Logic CR Slope ++ Tibial Inserts, Product Line 02-012-49-XXXX; f. OPTETRAK Logic CRC Tibial Inserts, Product Line 02-012-51-XXXX; g. OPTETRAK Logic CC Tibial Inserts, Product Line 02-012-65-XXXX; Affected 510(k) numbers include: K033883, K132161, K093360, K110547, K111400, K121307, K123342, K150890. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021