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

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    Infusion Set, Comfort, 23" Hosp 10; Comfort 13mm, 23", STD 5/5; Comfort 13mm, 23" Hosp 10; Infusion Set, Comfort, 43", Hosp 10; Infusion Set, Comfort, 31", Hosp 10; Comfort 13mm, 31". Hosp 10; Infusion Set, Comfort, 23", STD 5/6; Comfort 13mm, 43" Hosp 10; Infusion Set, Comfort 43", STD 5/5; Infusion Set, Comfort Short, 13mm x 23"; Infusion Set, Comfort Short, 13mm x 32"; Infusion Set, Comfort, 17mm x 32"' Infusion Set, Comfort Short, 13mm x 43"; Infusion Set, Comfort, 17mm x 43" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infusion Set, Contact Detach, 6mm x 32"; Infusion Set, Contact Detach, 8mm x 23"; Infusion Set, Contact Detach, 8mm x 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29 8mm, 23"; SureT G29 8mm, 23", Paradigm; SureT G29 8mm, 32"; SureT G29 8mm, 32", Paradigm; SureT G29 10mm, 32", Paradigm The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1 The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin

    FDA Enforcement
    Class II ·Terminated·Unomedical As·November 9, 2016

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Enforcement
    Class II ·Terminated·Unomedical As·July 1, 2015

    Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with Tandem Insulin Subcutaneous Infusion Pump.

    FDA Enforcement
    Class II ·Terminated·Unomedical A/S·October 5, 2022

    Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. RESPIREX Nebulizer Kits w/Aerosol Mask Adult 7 ft. (2.1m) Aerosol Tubing Manufactured for PSS World Medical Inc. Unomedical, Inc., Hospilak REF 100-E Aerosol Mask Adult Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; Unomedical, Inc., Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use MADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use Unomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, Adult with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eVal

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

    Unomedical Pediatric Manual Pulmonary Resuscitator, Child Mask & Reservoir Hose, Product ID # 779728

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Unomedical Adult Manual Pulmonary Resuscitator, Adult Medium Mask w/ Reservoir Bag. Product ID # 779725

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Unomedical Infant Manual Pulmonary Resuscitator, Infant Mask & Reservoir Hose. Product ID # 779733

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.

    FDA Recall
    Terminated ·Product code FPA·May 21, 2015

    Pediatric Manual Pulmonary Resuscitator. Product ID # 12-8708. Packaged under the name of Evergreen.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Pediatric Manual Pulmonary Resuscitator w/Luer-lock Sampling Elbow & Reservoir bag (No mask). Product ID# 12-8707. Packaged under the name of Evergreen.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Infant Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas sampling elbow. Product ID # 12-8714; 731-E, 731MM; 86-731E. Packaged under the name of Evergreen, Hospitak and McKesson.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Hospitak Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and Pop-Off 40 Cm H2O Elbow. Product ID # 735-E; Distributed in France only: product code: 40-116735.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Hospitak Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel Gas Sampling Elbow. Product ID #: 728-E.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Hospitak Adult Manual Pulmonary Resuscitator with reservoir bag, face mask & swivel gas sampling elbow. Foreign distribution only. Product code: 725-E,

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009

    Drager Medical Infant Manual Pulmonary Resuscitator with reservoir bag, face mask and swivel gas sampling elbow, Peep Valve. Product code: 40-116733, Distribution to France only.

    FDA Recall
    Terminated ·Unomedical·Product code BTM·October 6, 2009