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