15 results · 21ms · Sources: EU EUDAMED, US FDA

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MAMMOVISTA B.smart (VB70)

FDA 510(k)
FDA Class 2 ·Radiology

SUPER STAPLE(TM) CLASSIC

FDA 510(k)
FDA Class 2 ·Orthopedic

Crosser iQ CTO Recanalization System

FDA 510(k)
FDA Class 2 ·Cardiovascular

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·November 25, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 25, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 18, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 4, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 7, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC·Product code DZE·February 21, 2025

TENDRIL ST

FDA Adverse Event
Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·November 10, 2008

COLLEAGUE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 25, 2011

GREENLIGHT MOXY FIBER OPTIC

FDA Adverse Event
Injury ·AMERICAN MEDICAL SYSTEMS·Product code GEX·July 10, 2013

GLIDEWELL HT IMPLANT Ø4.3 X 8 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·July 17, 2025

MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

FDA Enforcement
Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

FDA Enforcement
Class I ·Terminated·Zimmer Biomet, Inc.·November 7, 2018