9 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RM Electrode (RMH 23-01)
FDA 510(k)
FDA Class 2
·Ophthalmic
ASTRA Spine System
FDA 510(k)
FDA Class 2
·Orthopedic
Cross Protection ResQ300 Plus Surgical Face Mask
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD MAX¿ CTGCTV2 (US)
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code QEP·April 14, 2026
INFINION? PRO
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·May 2, 2025
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM
FDA Adverse Event
Malfunction
·MAKO SURGICAL·Product code OLO·October 21, 2014
OR SOLUTIONS WARMER DRAPE
FDA Adverse Event
Malfunction
·OR SOLUTIONS·Product code KKX·August 15, 2011
TURBO-JECT DOUBLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC
FDA Adverse Event
Injury
·COOK, INC.·Product code FOZ·July 10, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025