BEUDAMED
    122 results · 38ms · Sources: EU EUDAMED, US FDA

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    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    FDA Enforcement
    Class II ·Terminated·Remel Inc·December 25, 2013

    COACH¿ Self-Adhering Sports Wrap (size: 2in)

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018

    COACH¿ Self-Adhering Sports Wrap (size: 3in)

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018

    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018

    Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018

    Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018

    Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 2in)

    FDA Enforcement
    Class II ·Terminated·Johnson & Johnson Consumer, Inc.·April 4, 2018

    Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves

    FDA Recall
    Terminated ·Adenna Inc·Product code LYY·December 22, 2011

    Drger Medical, REF 40314160, Bird-Bennet-Monaghan IPPB circuit, Latex Free, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

    FDA Recall
    Terminated ·Unomedical, Inc·Product code BZA·December 2, 2004

    Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber Latex; 1 pair of gloves per package, 100 packages per case; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malaysia

    FDA Recall
    Terminated ·Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia·Product code KGO·December 18, 2006

    Face Tent Hospilak Ref. No. 110-E, Face Tent, Adult No Tubing, Manufactured for Unomedical inc. Hospilak Ref. No. 111-E, Face Tent, Adult No Tubing, with 15mm OD Connector Manufactured for Unomedical inc. Hospilak Ref. No. 115-E, Face Tent, Adult 5 (1.5m) Tubing Manufactured for Unomedical inc. Hospilak Ref. No. 116-E, Face Tent, Adult 6 (1.8 m) Aerosol Tubing Manufactured for Unomedical inc. McKesson Aerosol Mask, Face Tent Adult, No Tubing Reorder No. 86-110E Face Tent Adult, 6 (1.8m) Aerosol Tubing Reorder no. 86-116E Smiths Medical Portex First Breath Adult Face Tent (Non-latex) Ref 001490 Smiths Medical Portex First Breath Adult Face Tent with Tubing, 188cm (5 ft.) (Non-latex) Ref 001492 Owens & Minor MediChoice Adult Face Tent Re-Order #RSP3000 and Face Tent, Adult 6 (1.8m) Aerosol Tubing Re-Order #RSP3060

    FDA Recall
    Terminated ·Convatec Inc.·Product code BYL·January 7, 2011

    Sterile Triumph LT Latex Powder-Free Surgeons Gloves; 50 pairs of gloves per box, 4 boxes per carton; Manufactured for Medline Industries, Inc., Mundelein, IL 60060 U.S.A., Made in Malayia

    FDA Recall
    Terminated ·Terang Nusa Sdn Bhd 1, Jalan 8, Pengkalan Chepa 2, Ind Zone Kota Bharu Malaysia·Product code KGO·May 23, 2006

    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

    FDA Recall
    Terminated ·Remel Inc·Product code JTO·May 2, 2013

    Latex-Free REF B1000, Belly Bag Urine Collection Bag with Hip Belt, ***1000 ml Lot***Sterile EO***Manufactured and Distributed by***Rusch Inc. 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 1

    FDA Recall
    Terminated ·Teleflex Medical, Inc.·Product code KNX·May 13, 2004

    Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****

    FDA Recall
    Terminated ·Teleflex Medical, Inc.·Product code KNX·May 13, 2004

    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005

    Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.

    FDA Recall
    Terminated ·Sandhill Scientific, Inc·Product code FAP·December 13, 2005

    Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code GCY·July 11, 2003

    Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

    FDA Recall
    Terminated ·Vital Concepts, Inc.·Product code BYY·November 7, 2003

    Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAI·August 23, 2012