14 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
BYTE DAY ALIGNERS
FDA Adverse Event
Malfunction
·STRAIGHT SMILE, LLC·Product code NXC·October 31, 2024
Byte Aligner System
FDA 510(k)
FDA Class 2
·Dental
MAESTRO TOTAL WRIST
FDA UDI
Biomet Orthopedics, LLC·00880304479401·
Maestro™ Total Wrist
FDA UDI
Biomet Orthopedics, LLC·00887868239731·
CLEANER ROTATIONAL THROMBECTOMY SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
ENDOCLEAR SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RD SET YI
FDA Adverse Event
Malfunction
·MASIMO - 52 DISCOVERY·Product code DQA·March 29, 2021
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·February 10, 2023
STYLE 15 SILICONE GEL FILLED BREAST IMPLANT
FDA Adverse Event
Injury
·ALLERGAN (COSTA RICA)·Product code FTR·June 22, 2021
WECK HEMOLOK L CLIPS 6/CART 84/BOX
FDA Adverse Event
Malfunction
·TELEFLEX·Product code MCH·October 15, 2014
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code KDJ·June 20, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 27, 2011
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025
RD SET
FDA Adverse Event
Malfunction
·MASIMO - 15750 ALTON PKWY·Product code DQA·December 31, 2025