13 results · 24ms · Sources: EU EUDAMED, US FDA

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INHANCETM Reverse Glenoid Peripheral Posts

FDA 510(k)
FDA Class 2 ·Orthopedic

EUROTROL HEMATOCRIT CONTROL

FDA 510(k)
FDA Class 2 ·Hematology

AUTOCON II 400 ELECTROSURGICAL GENERATOR

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

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

METRX SYSTEM

FDA Adverse Event
Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·April 16, 2024

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL·Product code FZP·November 25, 2014

CA090, DIRECT DRIVE LCA 3/BX

FDA Adverse Event
Malfunction ·APPLIED MEDICAL·Product code FZP·November 25, 2014

STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)

FDA Adverse Event
Malfunction ·STRYKER ENDOSCOPY-SAN JOSE·Product code LJH·November 3, 2014

LIFEVEST WCD 4000 SYSTEM

FDA Adverse Event
Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·August 17, 2011

ADVANTAGE SYSTEM

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 11, 2013

THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

FDA Adverse Event
Injury ·THORATEC CORPORATION·Product code DSQ·December 18, 2025

VIDAS® ESTRADIOL II

FDA Adverse Event
Malfunction ·BIOMÉRIEUX SA·Product code CHP·May 15, 2024

Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

FDA Enforcement
Class II ·Ongoing·Exactech, Inc.·April 10, 2024