8 results
·
34ms
·
Sources: EU EUDAMED, US FDA
SOLOS EYESITE SPONGES
FDA 510(k)
FDA Class 2
·Ophthalmic
FiberTak DX
FDA 510(k)
FDA Class 2
·Orthopedic
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647
FDA 510(k)
FDA Class 2
·Immunology
LOGIC TIBIA PS MOD INSRT SZ 4 13MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·March 12, 2024
UNKNOWN EXTERNAL STIMULATOR
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code EZW·June 13, 2014
RESTORE RECHARGABLE NEUROSTIMULATOR
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 12, 2010
PROTÉGÉ ®RX TAPERED CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·EV3 INC.·Product code NIM·December 13, 2012
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025