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

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MILESTONE SPINAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

FDA Adverse Event
Injury ·MEDTRONIC SOFAMOR DANEK, INC.·Product code MAX·May 9, 2019

ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM

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

VERIFY 270FP CHALLENGE PACK

FDA 510(k)
FDA Class 2 ·General Hospital

BIPAP A30-S SILVER

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

BIPAP A30, SILVER

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

CORNERSTONE-SR TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 11, 2018

BIPAP A30

FDA Adverse Event
Death ·RESPIRONICS, INC.·Product code MNS·September 13, 2023

SPRINT QUATTRO SECURE S

FDA Adverse Event
Death ·MPRI·Product code LWS·May 29, 2013

COLLEAGUE PRE P1.7

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 18, 2011

DEXTRUS 4135

FDA Adverse Event
Injury ·BIOTRONIK GMBH AND CO.·Product code DTB·August 21, 2008

JETSTREAM SC

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023

CORNERSTONE-SR TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·September 7, 2017

CORNERSTONE-SR® TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 6, 2025

CORNERSTONE-SR® TI-COATED CAGE SYSTEM

FDA Adverse Event
Malfunction ·MSD DEGGENDORF MFG·Product code ODP·October 8, 2024

BIPAP A30-S SILVER

FDA Adverse Event
Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

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