13 results · 25ms · Sources: EU EUDAMED, US FDA

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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