17 results
·
25ms
·
Sources: EU EUDAMED, US FDA
BRACE, TENNIS ELBOW
FDA 510(k)
FDA Class 1
·Physical Medicine
Helix
FDA UDI
Nuvasive, Inc.·00887517094667·Helix-T Clip, 2mm Spacer
Phonak
FDA UDI
Phonak AG·07613275471876·Lyric3 (S)
Sof-Flex Ureteral Stent Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MIRROR, LARYNGEAL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 24, 2024
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORP.·Product code FRN·January 6, 2014
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·October 10, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code NBW·August 2, 2010
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·September 30, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 7, 2024
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·October 21, 2024
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Injury
·COOK INC·Product code FAD·April 19, 2021
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc., an AngioDyamics Company·June 22, 2016
SOF-FLEX PEDIATRIC DOUBLE PIGTAIL URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·June 28, 2022
SOF-FLEX MULTI-LENGTH URETERAL STENT SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FAD·October 21, 2024