16 results · 26ms · Sources: EU EUDAMED, US FDA

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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