14 results · 22ms · Sources: EU EUDAMED, US FDA

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Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

FDA 510(k)
FDA Class 2 ·Ophthalmic

NEXT Coarse Wintergreen Prophy Paste Box 200

FDA UDI
Preventech·D024220263·NEXT Coarse Wintergreen Prophy Paste Box of 200...

Calibrator SET A, B

FDA UDI
TOKYO BOEKI MEDISYS INC.·04580262016019·

VOLUX 21C, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM

FDA 510(k)
FDA Class 2 ·Dental

LOGIQ 3

FDA 510(k)
FDA Class 2 ·Radiology

PUMP MMT-1780KPK 670G PATHWAY BLACK MG

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZP·December 10, 2018

T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

FDA Adverse Event
Malfunction ·TANDEM DIABETES CARE·Product code QFG·December 15, 2022

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS INC·Product code NBW·April 9, 2015

VERSYS HIP SYSTEM FEMORAL HEAD

FDA Adverse Event
Injury ·ZIMMER·Product code LPH·August 16, 2011

MAXI MOVE

FDA Adverse Event
Malfunction ·ARJO HOSPITAL EQUIPMENT AB·Product code FSA·October 31, 2008

RIATA ACTIVE FIXATION

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

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Recall
Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

Allura Xper FD10 Product Codes: (1)722010, (2) 722026, (3) 722003; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

FDA Enforcement
Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025

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

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