8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
SPECTRANETICS QUICK CROSS EXTREME SUPPORT CATHETERS
FDA 510(k)
FDA Class 2
·Cardiovascular
Streamline MIS Spinal Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 24, 2014
MESH - COMPOSIX KUGEL
FDA Adverse Event
Death
·DAVOL INC., SUB. C.R. BARD, INC.·Product code FTL·November 3, 2010
HEARTSINE SAMARITAN 300P AND PAD PAK
FDA Adverse Event
Malfunction
·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·November 30, 2012
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015