10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PTS PANELS LIPID PANEL TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ASKU
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code LWS·June 14, 2011
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
FDA Adverse Event
Malfunction
·Product code FKX·May 21, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·September 26, 2014
O-ARM O2 IMAGING SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC (LITTLETON)·Product code OWB·June 5, 2024
STEALTHSTATION¿ S8 SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 5, 2024
SMR CEMENTLESS FINNED STEM
FDA Adverse Event
Injury
·LIMACORPORATE S.P.A.·Product code HSD·April 8, 2022
Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, LEFT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-22, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-23, c) 44, 47, 50, 53 head, Large, Item Number 314-02-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-25; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024