BEUDAMED
    5 results · 29ms · 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.

    BOTTLEASE INC

    FDA registration
    BOTTLEASE INC·1 product·🇨🇦 Canada

    OXYSEPT

    FDA Adverse Event
    Malfunction ·JOHNSON & JOHNSON SURGICAL VISION, INC.·Product code LPN·July 3, 2020

    CONSEPT 1 STEP LL

    FDA Adverse Event
    Injury ·AMO(HANGZHOU) CO., LTD.·Product code LPN·August 28, 2023

    System O2, Portable Humidified Oxygen Delivery System Over 99% pure humidified oxygen. Safe, transportable and non-pressurized. Over one hour total humidified oxygen. Over 6 liters per minute volumetric humidified flow rate. Lightweight and easily portable. Reusable system. Environmentally acceptable. Refill packs available. Maintenance free. Box Includes Delivery system with Clear Base. 4 White Powder refills. 4 Black Powder refills. Water bottle. Nasal cannula. Medium concentration mask. Carry Case. Operating Instructions xxx, Directions: xxx, Caution: Federal Law (USA) restricts this device to sale by or on the order of a licensed physician.xxx, Applications: Unit is intended to provide oxygen for emergency use. Manufactured by System O2, Inc., 1090 Upper Hembree Road, Roswell, GA 30076-1140.

    FDA Recall
    Terminated ·System 02 Inc 1090 Upper Hembree Rd Roswell GA 300761140·Product code CAW·May 1, 2003

    Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the following brands and sizes: a.1) Ortho-Jet Powder, Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969, product code 1320, 100 g plastic squeeze bottle; a.2) Biocryl Resin Acrylic, Great Lakes Orthodontics, Ltd., P.O. Box 5111, Towanda, New York 14151-5111, product code 040-016, 1 lb. lab pack with empty plastic squeeze bottle; b.1) Contemporary Colored Ortho-Jet Powder, Lang Dental, product code 1520, 100 g plastic squeeze bottle; b.2) Contemporary Colored Assorted Kit, Great Lakes Orthodontics, product code 045-088, 2 oz. plastic squeeze bottles, 6 bottles per kit; c.1) Electric Colored Ortho-Jet Powder, Lang Dental, product code 2720, 100 g plastic squeeze botles and product code 2793, 45 g plastic squeeze bottles/6 per kit; c.2) Tropical Tones Acrylic Resin, Great Lakes Orthodontics, product code 045-052, 4 oz. plastic squeeze bottle

    FDA Recall
    Terminated ·Lang Dental Mfg Co, Inc.·Product code EBG·June 7, 2004