16 results · 23ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

HS NOTA

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Oticon

FDA UDI
Oticon A/S·05707131259509·NERA, KIT 13 WL DIR 90 L H BE

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 16, 2006

PROCEED TRILAMINATE SURGICAL MESH

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

PSYCHEMEDICS COCAINE EIA

FDA 510(k)
FDA Class 2 ·Clinical Toxicology

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 26, 2006

PROCEED MULTI-LAYER LAMINATE MESH

FDA Adverse Event
Injury ·ETHICON, INC.·Product code FTL·June 27, 2006

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019

STEALTHSTATION® S7´

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019

CART 9733856 S7 STAFF ASSEMBLED 110V

FDA Adverse Event
Malfunction ·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019

SYNCHROMED II

FDA Adverse Event
Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 29, 2013

MESH

FDA Adverse Event
Injury ·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·August 22, 2008

ENRHYTHM DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code DXY·June 16, 2011

MEDISLIM

FDA Adverse Event
Injury ·MEDICREATIONS, LLC·Product code GEX·April 27, 2020

Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No

FDA Enforcement
Class I ·Ongoing·Edwards Lifesciences, LLC·July 16, 2025