14 results · 18ms · Sources: EU EUDAMED, US FDA

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STRAPPED EYE SHIELD

FDA 510(k)
FDA Class 1 ·Ophthalmic

PUL-TRON 100K PROFESSIONAL SPIROMETER

FDA 510(k)
FDA Class 2 ·Anesthesiology

LATEX EXAMINATION GLOVES

FDA 510(k)
FDA Class 1 ·General Hospital

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

AUTOSOFT XC

FDA Adverse Event
Malfunction ·UNOMEDICAL A/S·Product code FPA·June 25, 2024

REGENCY SC+

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·November 10, 2010

SPECTRUM INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 22, 2014

9900

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·December 10, 2012

Exactech Equinoxe GLENOID, POSTERIOR AUGMENT,PEGGED, CEMENTED, 8o, RIGHT, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-02-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-02-33, c) 44, 47, 50, 53 head, Large, Item Number 314-02-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-02-35; Shoulder Arthroplasty

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