BEUDAMED
    27 results · 24ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Enforcement ×

    N Latex CDT Kit

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·September 5, 2018

    Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub CO2 Line STerm Lng , Adt/Pedi Intub CO2 Line High Humidity , Adt/Pedi Intub CO2 Line LTerm Lng , Adt/Pedi Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line LTerm , Neo/Inf Intub CO2 Line High Humidity , Neo/Inf Intub CO2 Line LTerm Lng , VitaLine H Set Adult/Pediatric , VitaLine H Set Infant/Neonatal , FilterLine Set Long Adult/Pediatric , FilterLine H Set Long Adult/Pediatric , FilterLine H Set Long Infant/Neonatal , Trade Compliant: FilterLine H, Adult/Ped , Trade Compliant: FilterLine H, Infant/Neo , FilterLine Set Adult/Pedi , FilterLine H Set Adult/Pedi and FilterLine H Set Infant/Neonatal. Carbon dioxide gas analyzer.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 14, 2025

    Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-deficient transferrin (CDT) in human serum. Siemens Material Number (SMN): 10445997

    FDA Enforcement
    Class II ·Terminated·CSL Behring GmbH·April 29, 2020

    Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CUFFED TRACH CAN; 10CN10R, 10.0MM ADT FLEX TRACH W TG CUFF; 10UN10A, 10.0MM UNCUFF TRACH TUBE X1; 10UN10H, 10.0MM SHILEY CUFFLESS TRACH C; 10UN10R, 10.0MM ADT FLEX TRACH CUFFLESS; 4CN65A, 6.5MM TRACH TUBE W TG CUFF X1; 4CN65H, 6.5MM SHILEY CUFFED TRACH CANN; 4CN65R, 6.5MM ADT FLEX TRACH W TG CUFF X1; 4UN65A, 6.5MM UNCUFF TRACH TUBE X1; 4UN65H, 6.5MM SHILEY CUFFLESS TRACH CA; 4UN65R, 6.5MM ADT FLEX TRACH CUFFLESSX1; 5CN70A, 7.0MM TRACH TUBE W TG CUFF X1; 5CN70H, 7.0MM SHILEY CUFFED TRACH CANN; 5CN70R, 7.0MM ADT FLEX TRACH W TG CUFF X1; 5UN70A, 7.0MM UNCUFF TRACH TUBE X1; 5UN70H, 7.0MM SHILEY CUFFLESS TRACH CA; 5UN70R, 7.0MM ADT FLEX TRACH CUFFLESSX1; 6CN75A, 7.5MM TRACH TUBE W TG CUFF X1; 6CN75H, 7.5MM SHILEY CUFFED TRACH CANN; 6CN75R, 7.5MM ADT FLEX TRACH W TG CUFF X1; 6UN75H, 7.5MM SHILEY CUFFLESS TRACH CA; 6UN75R, 7.5MM ADT FLEX TRACH CUFFLESSX1; 7CN80A, 8.0MM TRACH TUBE W TG CUFF X1; 7CN80H, 8.0MM SHILEY CUFFED TRACH CANN; 7CN80R, 8.0MM ADT FLEX TRACH W TG CUFF X1; 7UN80A, 8.0MM UNCUFF TRACH TUBE X1; 7UN80H, 8.0MM SHILEY CUFFLESS TRACH CA; 7UN80R, 8.0MM ADT FLEX TRACH CUFFLESSX1; 8CN85A, 8.5MM TRACH TUBE W TG CUFF X1; 8CN85H, 8.5MM SHILEY CUFFED TRACH CANN; 8CN85R, 8.5MM ADT FLEX TRACH W TG CUFF X1; 8UN85A, 8.5MM UNCUFF TRACH TUBE X1; 8UN85H, 8.5MM SHILEY CUFFLESS TRACH CA; 8UN85R, 8.5MM ADT FLEX TRACH CUFFLESSX1; 9CN90H, 9.0MM SHILEY CUFFED TRACH CANN; 9CN90R, 9.0MM ADT FLEX TRACH W TG CUFF X1; 9UN90H, 9.0MM SHILEY CUFFLESS TRACH CA; 9UN90R, 9.0MM ADT FLEX TRACH CUFFLESSX1

    FDA Enforcement
    Class I ·Ongoing·Covidien·April 26, 2023

    Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·July 3, 2024

    Merge OrthoPACS software. The firm name on the label is Merge Healthcare, Hartland, WI.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·June 28, 2017

    Merge PACS software. The firm name on the label is Merge Healthcare.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·March 15, 2017

    CHS Custom Convenience Kit- (1) DT SCATPAD, DBL. TAPE, 12.5 X 16.5 Product Number: SEPA 402 (2) SCATPAD, 11 X 34 Product Number: SPA502

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·October 31, 2018

    LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow Adt 8¿ SpCO, SpO2, and SpMet, Adult Adhesive Sensors REF 11996-000515 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Adult Reusable Sensor REF 11996-000519 Masimo¿ LNCS-II rainbow¿ DCI 8¿ SpCO, Pediatric Reusable Sensor REF 11996-000520 The LIFEPAK¿ 15 Monitor/Defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. RD rainbow" 8¿ SpCO sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO¿), and methemoglobin saturation (SpMet¿) for use with adult, pediatric, infant, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.

    FDA Enforcement
    Class II ·Ongoing·Physio-Control, Inc.·February 26, 2025

    The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic strains Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile.

    FDA Enforcement
    Class II ·Terminated·Nanosphere, Inc.·October 1, 2014

    Roche cobas IT 1000 Product Usage: Intended Use: An electronic device intended to store, retrieve, and process laboratory data.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·September 10, 2014

    Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.

    FDA Enforcement
    Class III ·Terminated·Nanosphere, Inc.·August 20, 2014

    Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr

    FDA Enforcement
    Class II ·Terminated·Pdg Product Design Group Inc·October 1, 2014

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101463MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101463DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020

    Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.

    FDA Enforcement
    Class II ·Terminated·Degania Medical Devices Pvt. Ltd.·April 29, 2020