14 results
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36ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clyra Wound Irrigation Solution
FDA 510(k)
FDA Unclassified
·Unknown
TASMIN R 18°
FDA UDI
SIGNUS Medizintechnik GmbH·04047844015087·The basic shape of the TASMIN R devices is a ho...
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780361862·Integra® Miltex® Knapp Iris Scissors 4-1/8", Cu...
OTSC (OVER-THE SCOPE-CLIP) SYSTEM SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR
FDA 510(k)
FDA Class 2
·Orthopedic
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·Product code OZO·October 17, 2014
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code MPA·July 6, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 21, 2013
BD MAX¿ SYSTEM, BD MAX¿ INSTRUMENT
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code OOI·September 10, 2021
KIT BD MAX ENTERIC VIRAL PANEL
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code PCH·October 3, 2022
BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·October 27, 2022
BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·October 27, 2022
BD TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR
FDA Adverse Event
Malfunction
·BECTON DICKINSON IND. CIRURGICAS LTDA·Product code JKA·October 27, 2022
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021