14 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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