14 results · 23ms · Sources: EU EUDAMED, US FDA

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Maestro System (REF100)

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

Riofoto™ Mirrors

FDA UDI
Ortho Organizers, Inc.·00190707055769·Riofoto™ Photo Mirror Lingual (Wide)

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·April 20, 2026

BIOPLANT

FDA 510(k)
FDA Class 2 ·Dental

Guardian Needle Electrode

FDA 510(k)
FDA Class 2 ·Neurology

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code NGT·May 1, 2026

BD POSIFLUSH

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

BD POSIFLUSH

FDA Adverse Event
Malfunction ·BECTON DICKINSON, S.A.·Product code NGT·March 20, 2026

POSIFLUSH

FDA Adverse Event
Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FOZ·April 6, 2026

HEART START XL

FDA Adverse Event
Malfunction ·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·August 31, 2011

LINEAGE(R) SHELL

FDA Adverse Event
Injury ·MICROPORT ORTHOPEDICS INC.·Product code LPH·November 14, 2014

HOMECHOICE AUTOMATED PD SET WITH CASSETTE

FDA Adverse Event
Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2013

BD VACUTAINER® SST¿ TUBE

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·February 13, 2019

Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder Arthroplasty

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