19 results · 22ms · Sources: EU EUDAMED, US FDA

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CLEARFIL AP-X PLT

FDA 510(k)
FDA Class 2 ·Dental

RZ Medizintechnik GmbH

FDA UDI
RZ-Medizintechnik GmbH·04049197470742·Farrior Specula, oval Ø 4.8x...

Epatch Electrode-patch

FDA UDI
BRAEMAR MANUFACTURING, LLC·B146EPE20·

TRIAGE TOX DRUG SCREEN CALIBRATION VERIFICATION CONTROLS, CATALOG #94002

FDA 510(k)
FDA Class 1 ·Clinical Toxicology

STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123

FDA 510(k)
FDA Class 2 ·General Hospital

GRAVES VAG SPECULUM MEDIUM 4 X 1-3/8IN

FDA Adverse Event
Malfunction ·CAREFUSION, INC·Product code HDF·February 23, 2023

EON MINI

FDA Adverse Event
Injury ·ST. JUDE MEDICAL- NEUROMODULATION·Product code GZB·December 10, 2013

CARDIOSAVE HYBRID W/ E/F PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·April 4, 2024

HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07, PAD-PAK-03J, PAD-PAK-04J

FDA Enforcement
Class II ·Ongoing·HeartSine Technologies Ltd·October 29, 2025

SINGLE USE DISTAL COVER

FDA Adverse Event
Injury ·OLYMPUS MEDICAL SYSTEMS CORP. HINODE PLANT·Product code FDT·August 19, 2025

STEM: AMISTEM C CEMENTED STD STEM SIZE 2

FDA Adverse Event
Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·April 27, 2021

PROMUS ELEMENT¿ PLUS

FDA Adverse Event
Injury ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·March 27, 2013

PULSE GEN MODEL 104

FDA Adverse Event
Malfunction ·CYBERONICS, INC.·Product code LYJ·February 24, 2011

COLLEAGUE CX VOLUMETRIC INFUSION PUMP

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·April 3, 2008

RAPIDPOINT 500E BLOOD GAS SYSTEM

FDA Adverse Event
Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code CHL·June 18, 2024

CERELINK ICP MONITOR

FDA Adverse Event
Malfunction ·INTEGRA LIFESCIENCES MANSFIELD·Product code GWM·December 22, 2023

CARDIOSAVE HYBRID, TYPE B PLUG

FDA Adverse Event
Malfunction ·DATASCOPE CORP.·Product code DSP·February 8, 2024

ZIO AT

FDA Adverse Event
Malfunction ·IRHYTHM TECHNOLOGIES, INC·Product code QYX·December 29, 2023

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