BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045

    FDA 510(k)
    FDA Unclassified ·Unknown

    MINI PULL THRU SINGLE

    FDA UDI
    MEDIVATORS INC.·40677964021570·

    GRADIA®

    FDA UDI
    Gc America Inc.·D0470025991·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30...

    GRADIA®

    FDA UDI
    Gc America Inc.·14548161322263·GRADIA® DIRECT X Unitips - 10 tips 0.16 mL/0.30...

    STERILE Touchproof Cable Yellow

    FDA UDI
    Synapse Biomedical, Inc.·00852184003175·

    ACTI-FLEX IV ADMINISTRATION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VITALOGRAPH BASE STATION

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205000342·

    RESTORE SENSOR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013

    AED PLUS

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·February 4, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Malfunction ·CORDIS LLC PR·Product code NIQ·February 8, 2008

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Recall
    Terminated ·Synapse Biomedical Inc·Product code OIR·May 31, 2022

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022

    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·March 27, 2013

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022