17 results · 25ms · Sources: EU EUDAMED, US FDA

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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