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

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Puffin Lite Infant Resuscitation System

FDA 510(k)
FDA Class 2 ·Anesthesiology

ALPHA ORTHOPAEDICS AT2 SYSTEM

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

V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSING

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

21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 29, 2017

BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER.

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·November 29, 2017

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·October 17, 2014

FOGARTY ARTERIAL EMBOLECTOMY CATHETER

FDA Adverse Event
Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·July 28, 2011

MINICAP TRANSFER SET

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 21, 2013

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Injury ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·May 21, 2021

PRUITT F3 CAROTID SHUNT

FDA Adverse Event
Malfunction ·LEMAITRE VASCULAR, INC.·Product code MJN·April 23, 2021

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024