16 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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