8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
RK-M & RK-DK DIAMOND KNIVES WITH MEASURING GAUGE
FDA 510(k)
FDA Class 1
·Ophthalmic
6864290
FDA Adverse Event
Malfunction
·September 14, 2017
L100D PATIENT CIRCUIT DUAL LINE
FDA 510(k)
FDA Class 1
·Anesthesiology
INSPIRON LIQUID OXYGEN SYSTEM
FDA 510(k)
FDA Class 2
·Anesthesiology
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 10, 2014
PULSE GEN MODEL 102R
FDA Adverse Event
Injury
·CYBERONICS INC.·Product code LYJ·October 7, 2010
DLT TS CER HD 12/14 32MM +9
FDA Adverse Event
Injury
·DEPUY INTL., LTD. ¿ REG. # 8010379·Product code LZO·December 10, 2012
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021