12 results · 21ms · Sources: EU EUDAMED, 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