16 results · 20ms · Sources: EU EUDAMED, US FDA

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MEPITEL AG

FDA 510(k)
FDA Unclassified ·Unknown

OsteoMed

FDA UDI
OSTEOMED LLC·00845694003131·Right L Plate, 6mm, Rigid

Vasomedical™ EZ™ Software CD & Data Cable for ECG Monitor

FDA UDI
VASOMEDICAL, INC.·00817980021396·EZ™ Software CD & Data Cable for ECG Monitor

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776188733·FLEXIBLE SINGLE ACTION BIOPSY FORCEPS

Mariner Outrigger

FDA UDI
Seaspine Orthopedics Corporation·10889981175733·Z-Rod, Dia. 6.0mm, Titanium, 40mm

Millennium

FDA UDI
Avalign Technologies, Inc.·00190776301101·3FR 120CM FLEXIBLE SINGLE ACTION BIOPSY FORCEPS

LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)

FDA 510(k)
FDA Class 2 ·Orthopedic

BIOHARNESS

FDA 510(k)
FDA Class 2 ·Cardiovascular

BINAX NOW COVID-19 AG CARD

FDA Adverse Event
Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·April 13, 2021

TREK¿

FDA Adverse Event
Malfunction ·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026

INTERSTIM II

FDA Adverse Event
Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·May 24, 2013

STAPLE, IMPLANTABLE

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·September 30, 2014

NEPTUNE 2 DOCKING STATION (120V)

FDA Adverse Event
Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code FYD·May 5, 2011

INRATIO

FDA Adverse Event
Malfunction ·BIOSITE INCORPORATED·Product code GJS·December 4, 2009

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

Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

FDA Enforcement
Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015