19 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: 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