16 results · 29ms · Sources: EU EUDAMED, US FDA

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Arthrex SwiveLock Anchors

FDA 510(k)
FDA Class 2 ·Orthopedic

CoRoent

FDA UDI
Nuvasive, Inc.·00887517637949·CoRoent Ant TLIF PEEK, 15x11x34mm 12°

Sklar®

FDA UDI
SKLAR CORPORATION·10649111144684·SKLHN STEVENS SCISS CVD BL 4.5

MEDICAL INTERPOROUS

FDA 510(k)
FDA Class 1 ·Dental

OSIRIX MD

FDA 510(k)
FDA Class 2 ·Radiology

OSSURE LOEP KIT

FDA Adverse Event
Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

OSSURE LOEP KIT

FDA Adverse Event
Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

CONTOUR® NEXT

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·September 4, 2025

ITST ONE-PIECE NAIL CAP

FDA Adverse Event
Malfunction ·ZIMMER, INC.·Product code HSB·May 30, 2013

CENTRA BED

FDA Adverse Event
Malfunction ·HILL-ROM INC.·Product code FNL·June 7, 2011

PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

FDA Adverse Event
Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 8, 2014

XIA TITANIUM 4.5 BLOCKER

FDA Adverse Event
Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 2020

CONTOUR® PLUS

FDA Adverse Event
Malfunction ·ASCENSIA DIABETES CARE US INC.·Product code JJX·February 20, 2025

20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.

FDA Enforcement
Class II ·Terminated·Biosense Webster, Inc.·April 3, 2013

Medical Linear Accelerator

FDA Enforcement
Class II ·Terminated·Elekta, Inc.·September 14, 2016

KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

FDA 510(k)
FDA Class 2 ·Neurology