13 results
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25ms
·
Sources: EU EUDAMED, US FDA
RELY TAMPON
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BonAlive Granules
FDA 510(k)
FDA Class 2
·Orthopedic
CORONIS 5MP HD, MODEL MDMG 5121
FDA 510(k)
FDA Class 2
·Radiology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·August 6, 2010
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·October 30, 2014
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Injury
·SYNTHES TUTTLINGEN·Product code HTD·October 30, 2014
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·October 30, 2014
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code HTD·October 30, 2014
REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
FDA Adverse Event
Malfunction
·SYNTHES TUTTLINGEN·Product code HTD·October 30, 2014
HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11, 32151-12, 32151-13, 32151-14, 32151-15, 32151-16, 32151-18, 32151-20. 2. HLS Plate, 2 T-Shape; Article Numbers: 21505-4, 21506-4. 3. HLS Plate, 3 T-Shape; Article Numbers: 21507-4, 21508-4. 4. HLS Plate, Square; Article Numbers: 21517. 5. HLS Plate, Straight; Article Numbers: 21502, 21503-4, 21503-6, 21503-8, 21503-10, 21504-6, 21504-8, 21504-10. 6. HLS Plate, Y-Shape; Article Numbers: 21513-3, 21513-5, 21514-3, 21514-5. 7. Locking Stabilization Screw; Article Numbers: 37151-5, 37151-8, 37151-9, 37151-10, 37151-12, 37151-13, 37151-15, 37151-16, 37151-18, 37151-24, 37251-8, 37251-9, 37251-11, 37251-12, 37251-13, 37251-14, 37251-16, 37251-20.
FDA Enforcement
Class II
·Ongoing·I.T.S. GmbH·April 1, 2026
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025