25 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ALARIS SYSTEM PC UNIT, MODEL 8001
FDA 510(k)
FDA Class 2
·General Hospital
XTD THROMBECTOMY CATHETER, XX CM
FDA 510(k)
FDA Class 2
·Cardiovascular
TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD POSIFLUSH¿ PRE-FILLED SALINE SYRINGE
FDA Adverse Event
Malfunction
·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMF·January 15, 2018
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
PERCLOSE¿ PROSTYLE¿
FDA Adverse Event
Injury
·ABBOTT VASCULAR INC.·Product code MGB·September 6, 2024
DEPUY ASR XL FEM IMP SIZE 43
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·April 10, 2013
SILICONE ADVANCED OPTIC-VIOLET SHIELD
FDA Adverse Event
Malfunction
·BAUSCH & LOMB·Product code HQL·May 19, 2008
COGNIS
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 12, 2011
10MM/130 DEG TI CANN TFNA 200MM - STERILE
FDA Adverse Event
Injury
·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·May 2, 2019
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023