13 results · 20ms · Sources: EU EUDAMED, US FDA

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VARI-LASE WIRE FIBER

FDA 510(k)
FDA Class 2 ·General, Plastic Surgery

MEDI

FDA UDI
MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

Channel Drain

FDA UDI
C. R. Bard, Inc.·00801741049996·Channel Drain, 32 Fr. Round Hubless Full Fluted

JAS CARBON DIOXIDE LIQUID REAGENT

FDA 510(k)
FDA Class 2 ·Clinical Chemistry

EEG SPIKE AND EVENT DETECTOR MODULE

FDA 510(k)
FDA Class 2 ·Neurology

SUTRLASSO SD SFT,25°TIGHT LFT CRV,R

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·January 23, 2026

SUTRLASSO SD SFT,45°RT CRV,R

FDA Adverse Event
Malfunction ·ARTHREX, INC.·Product code LXH·January 23, 2026

SPECTRA WAVEWRITER

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 20, 2021

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·April 5, 2013

SYNCHRON® LX®I 725 CLINICAL SYSTEM

FDA Adverse Event
Malfunction ·BECKMAN COULTER INC.·Product code JJE·April 28, 2011

CAPSUREFIX

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·July 10, 2008

EVOLUT FX VALVE

FDA Adverse Event
Injury ·MEDTRONIC MEXICO S. DE R.L. DE CV·Product code NPT·August 27, 2025

I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.

FDA Enforcement
Class II ·Ongoing·I.T.S. GmbH·April 1, 2026