15 results · 23ms · Sources: EU EUDAMED, 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 SàRL CH·Product code NKB·February 18, 2020

VERSE CORRECTION KEY

FDA Adverse Event
Malfunction ·MEDOS INTERNATIONAL SàRL 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