16 results
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26ms
·
Sources: EU EUDAMED, US FDA
STANBIO CSF/URINE TOTAL PROTEIN TEST SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814671·GENUMEDI SILVER SIZE IV
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·00636257024393·OMOMED SHOULDER SUP SILVER LEFT SIZE IV
BONE-LOK MVP Cortical-Cancellous Compression Device
FDA UDI
INTERVENTIONAL SPINE, INC·81195401194924·3.5mm Diameter x 20-25mm Length
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123854·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 100mm
Maestro®
FDA UDI
Ortho Organizers, Inc.·00190707047474·.018 UL6 NC Std -14T 0A 10DO
PMD VIEWER
FDA 510(k)
FDA Class 2
·Radiology
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
FDA 510(k)
FDA Class 2
·Cardiovascular
POLARIS ADJUSTABLE VALVE
FDA Adverse Event
Injury
·SOPHYSA·Product code JXG·June 19, 2014
UNKNOWN DEPUY HV BONE CEMENT
FDA Adverse Event
Injury
·DEPUY CMW·Product code LOD·November 15, 2010
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·January 8, 2013
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
STEALTH 32 LHOOK LAP ELEC PKG
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·November 12, 2021
EVOLUT FX DCS
FDA Adverse Event
Malfunction
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·June 25, 2025
DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460
FDA Enforcement
Class II
·Ongoing·Beckman Coulter, Inc.·August 13, 2025
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012