15 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)
FDA 510(k)
FDA Class 2
·Neurology
Meridian
FDA UDI
Seaspine Orthopedics Corporation·10889981247324·No-Profile Interbody, 39mm x 30mm x 14mm, 25 Deg
K231485
FDA Adverse Event
Malfunction
·BETA BIONICS, INC.·Product code QFG·October 25, 2025
GENTLEWAVES LED PHOTOMODULATION DEVICE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
FDA 510(k)
FDA Class 2
·Neurology
VERSE CORRECTION KEY
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·February 18, 2020
VERSE CORRECTION KEY
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SÃ RL CH·Product code NKB·February 13, 2020
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 4, 2019
STEALTHSTATION® S7´
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 20, 2019
CART 9733856 S7 STAFF ASSEMBLED 110V
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC·Product code HAW·June 17, 2019
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·July 18, 2011
FG 6301 DUAL CHNL VOL INF PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE (SG)·Product code FRN·November 17, 2008
SINGLE EXTENSION
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·July 12, 2013
INRATIO PT/INR TEST STRIPS
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·August 9, 2016
Revogene, Catalog no. 610210. IVD test instrument
FDA Enforcement
Class II
·Ongoing·Meridian Bioscience Inc·August 3, 2022