12 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
FDA 510(k)
FDA Class 2
·Cardiovascular
NANO COMPOSITE
FDA 510(k)
FDA Class 2
·Dental
SENSITITRE OPTIREAD
FDA 510(k)
FDA Class 2
·Microbiology
OT ULTRA2 METER
FDA Adverse Event
Injury
·LIFESCAN INC.·Product code NBW·July 21, 2011
MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP
FDA Adverse Event
Injury
·MEDTRONIC·Product code LKK·April 12, 2013
NONE
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROSURGERY·Product code JXG·September 16, 2008
T-HANDLE INSERTER
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·April 29, 2021
T-HANDLE
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code LXH·May 2, 2023
IMPLANT INSERTER SH CONNECTION
FDA Adverse Event
Malfunction
·EIT EMERGING IMPLANT TECHNOLOGIES GMBH·Product code MAX·May 2, 2023
TORNIER PERFORM ANATOMIC AUG MED RIGHT GLENOID 15 DG
FDA Adverse Event
Injury
·TORNIER INC·Product code KWS·March 8, 2024
NV EHXL ALIP LNR G4 36MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JDI·October 18, 2022
CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·August 14, 2024