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

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Diode Laser Therapy Systems

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

MiniDam

FDA UDI
DMG Chemisch-Pharmazeutische Fabrik GmbH·EDMG2203811·Gingival guard, silicone. Content: 20 Pieces

EXPANDABLE KNEE

FDA 510(k)
FDA Class 2 ·Orthopedic

Q50 PLUS STENT GRAFT BALLOON CATHETER

FDA 510(k)
FDA Class 2 ·Cardiovascular

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 3, 2025

DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 15, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

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

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·September 3, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT INC.·Product code DZE·April 16, 2025

GLIDEWELL HT IMPLANT Ø4.3 X 10 MM

FDA Adverse Event
Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·April 30, 2025

INFINITI VISION SYSTEM

FDA Adverse Event
Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·October 31, 2008

WIDE PORE POLYPROPELENE PRODUCT

FDA Adverse Event
Injury ·AMS·Product code FTL·August 17, 2011

ATLAS II PLUS DR

FDA Adverse Event
Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2013

BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

FDA Enforcement
Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

FDA Enforcement
Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025

ACCOLADE DR SL MRI (Model L311)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025