BEUDAMED
    1,714 results · 25ms · 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 × Status: Terminated × Clear all

    reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Enforcement
    Class II ·Terminated·Pear Therapeutics, Inc.·June 30, 2021

    reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.

    FDA Enforcement
    Class II ·Terminated·Pear Therapeutics, Inc.·June 30, 2021

    LAMINECTOMY PACK - ( I) RING BASIN LIF (2) TABLE COVER REINFORCED 50" X 90" LIF ( I) SKIN MARKER INK W/8 LABEL ( I) CAUTERY TIP POLISHER LIF ( I) TUBE SUCTION CONNECT. W' X 12' LIF (6) DRAPE UTILITY W/TAPE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (2) UTILITY BOWL 16oz. LIF ( IO) LAP SPONGE PRE-WASH XRD LIF (2) SPECIMEN CONTAINER 4oz W/LID & LABEL (2) MAYO STAND COVER REINFORCED LIF ( I) GOWN SURG. REINF. XL TOWEL WRAP (6) ABSORBENT TOWEL I5" X 20" LIF ( I) DRAPE LAP 102" X 121" X 78" W/POUCI-1 SMS LIF ( I) SURGICAL DURAPREP SOLUTION 26ML LIF (6) DRAPE SHEET 41" X 69" MEDIUM LIF (2) LEGGING W/7'' CUFF 30" X 42" LIF (2) NEEDLE & BLADE COUNTER I Oc MAG /CLEAR ( I) CAUTERY PENCIL PUSH BOTTOM LIF ( I) BAG SUTURE FLORAL LIF ( I) PVP SCRUB 8" STICK SPONGE ( I) MAYO TRAY LARGE LIF (I 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF ( I) SURGICAL BLADE# I 0 CARBON STEEL (2) BULB SYRINGE 60cc CLEAR LIF ( I) SURGICAL BLADE# I I CARBON STEEL ( I) SURGICAL BLADE # 15 CARBON STEEL ( I) GOWN FABRIC REINFORCED SONTARA XL LIF ( I) SYRINGE IOcc W/NDL 20G X I Y, LILOCK LIF ( I) PVP PAINT 8" STICK SPONGE ( I) SURGICAL STRIP W' X 6" COTTON (2) LITE GLOVES LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79" X 110" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8" X 1 8" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53" X 77" LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02" X 78" X 1 21 " STD SMS Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

    FDA Enforcement
    Class I ·Terminated·Customed, Inc·September 10, 2014

    iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.

    FDA Enforcement
    Class II ·Terminated·Otto Bock Healthcare GmbH·November 11, 2015

    THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.

    FDA Enforcement
    Class II ·Terminated·Bios S.r.l.·November 8, 2017

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Single. Part number: 8900-4013 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories·September 26, 2012

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    Medsolutions4U Multi-Function Electrodes to be used with PhysioControl Lifepak Defibrillators, models 9, 10C, 11, 12, 15, 20, 500 and are indicated for Defibrillation, Cardioversion, Pacing, and Monitoring Part Number: 2033

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 10, 2014

    ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires, 1 single Part number: 8900-4055-40 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ National Standards, EN ISO 11137-2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·October 15, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes with 10-ft (3 m) leadwires Part number: 8900-4052 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes Part number: 8900-4012 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or upgrade software used with the EVOLIS Microplate System.

    FDA Enforcement
    Class III ·Terminated·Bio-Rad Laboratories·October 30, 2013

    ZOLL Pro-padz Sterile Adult Multi-Function Electrodes ((singles) Part number: 8900-4013 These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFE's are processed through Gamma Radiation to a SAL of 1 o.e per International/ National Standards, EN ISO 11137- 2:2012 and ANSI/AAMI/ISO 11137-2:2013, Method 1, for use in a sterile environment by trained medical professionals. The indications for use include defibrillation, cardioversion, external non-invasive pacing and monitoring. These MFE electrodes have a 12 month shelf life from time of manufacture.

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·September 24, 2014

    ZOLL Pro-padz Liquid Gel Radiolucent, Part numbers: 8900-2105-01 (12/case) and 8900-2106-01 (single)

    FDA Enforcement
    Class II ·Terminated·Bio-Detek, Inc.·July 10, 2019

    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.

    FDA Enforcement
    Class III ·Terminated·Bio-Rad Laboratories, Inc.·July 1, 2015

    MRSASelect II, IVD, REF 63758 (20 plates per package). The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories, Inc·June 12, 2019

    MRSASelect, IVD, REF 63747, containing 20 plates per package. The MRSASelect is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections.

    FDA Enforcement
    Class II ·Terminated·Bio-Rad Laboratories, Inc·June 12, 2019