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

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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