12 results
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20ms
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Sources: EU EUDAMED, US FDA
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
COMFEEL POWDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PDI PREPMASTER WET PACK VAGINAL-X21477
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 8.5 F
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL·Product code DYB·January 22, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 2, 2014
VISIONAIRE
FDA Adverse Event
Malfunction
·AIRSEP CORP.·Product code CAW·November 8, 2012
HOMECHOICE CYCLER-REFURBISHED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·September 24, 2010
3.5MM TI LOCKING SCREW SELF-TAPPING 24MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·August 6, 2018
3.5MM TI CORTEX SCREW SELF-TAPPING 24MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·July 16, 2018
3.5MM TI LOCKING SCREW SELF-TAPPING 24MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code KTT·July 17, 2018
3.5MM TI CORTEX SCREW 28MM
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·August 6, 2018
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·September 21, 2022