18 results
·
21ms
·
Sources: EU EUDAMED, US FDA
WAVi Headset and WAVi eSoc Single Use Electrode Contacts
FDA 510(k)
FDA Class 2
·Neurology
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B16741624600·
TALOS® IBF
FDA UDI
MEDITECH SPINE, LLC·B1674162460060·
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X1624600·16mm H x 24mm W x 60mm L x 0 degrees XLIF
Suprasorb
FDA UDI
Lohmann & Rauscher International GmbH & Co KG·04068225066924·
Millennium
FDA UDI
Avalign Technologies, Inc.·00190776380960·Finochietto Needle Holder, 8"
WILDER LACRIMAL DILATOR
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896018488·WILDER LACRIMAL DILATOR SINGLE ENDEDFINE TIP #1
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X162460120·16mm H x 24mm W x 60mm L x 12 degrees XLIF
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587L162460120·16mm H x 24mm W x 60mm L XLIF Trial 12 degree L...
Yellowstone
FDA UDI
SUMMIT SPINE LLC·B587X16246080·16mm H x 24mm W x 60mm L x 8 degrees XLIF
Softouch®
FDA UDI
Merit Medical Systems, Inc.·00884450082621·
AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
FDA 510(k)
FDA Class 2
·Anesthesiology
VITROS CHEMISTRY PRODUCTS OP REAGENT, CALIBRATOR KIT 26 AND DAT PERFORMANCE VERIFIERS I, II AND III
FDA 510(k)
FDA Class 2
·Clinical Toxicology
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·October 10, 2014
THERAKOS XTS PHOTOPHERESIS SYSTEM
FDA Adverse Event
Malfunction
·THERAKOS·Product code LNR·June 6, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011
Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic implants for Proximal Humeral Reconstruction, Distal Humeral Reconstruction, and Total Humeral Reconstruction
FDA Enforcement
Class II
·Terminated·Biomet, Inc.·April 4, 2018
Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026