Applicator (laryngo-tracheal), Topical Anesthesia
Anesthesiology · 21 CFR 868.5170
Recent MDR events
24 adverse event reports on file
- MADGIC ATOMIZER WITHOUT SYRINGEApr 8, 2026InjuryTeleflex Medical3003898360-2026-00169
- MADGIC ATOMIZER WITH 3 ML SYRINGESep 19, 2025InjuryTeleflex Medical3003898360-2025-00700
- LARYNG-O-JET KIT STERILE PAK STERILE LAYRYNGOTRACHEAL CANNULAJan 2, 2025InjuryInternational Medication Systems, LtdMW5164188
- LARYNG-O-JET KITSep 11, 2024InjuryInternational Medication Systems/amphastar Pharmaceuticals, Inc.MW5159528
- DART-REACHJan 30, 2024MalfunctionPulmodyne Inc18606234
- MADGIC LARYNGO-TRACHEAL MUCOSAL ATOMIZATIONDec 26, 2023OtherTeleflex MedicalMW5149588
- DART-REACHJun 5, 2023MalfunctionPulmodyne Inc17057554
- LARYNG-O-JETSep 13, 2022InjuryInternational Medication Systems Limited15412248
- MADGIC LARYNGO-TRACHEAL MUCOSAL ATOMIZATJul 21, 2022MalfunctionTeleflex Medical3011137372-2022-00127
- LMA ATOMIZATIONJun 28, 2022MalfunctionTeleflex Medical14843383
Event type breakdown
Recalls
6 recall events for this product code
- Teleflex MedicalTerminatedAug 25, 2017
LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c)
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Z-3212-2017 · View FDA record ↗ - Teleflex MedicalTerminatedNov 9, 2016
LMA MADgic, Atomization Device with 3mL Syringe, Rx only,
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Z-0384-2017 · View FDA record ↗ - Sharn, Inc.TerminatedNov 16, 2009
Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA.
Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
Z-0265-2010 · View FDA record ↗ - Sharn, Inc.TerminatedNov 16, 2009
Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
Z-0266-2010 · View FDA record ↗ - Sharn, Inc.TerminatedNov 16, 2009
Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
Z-0267-2010 · View FDA record ↗ - Teleflex Medical Europe LtdTerminatedUnknown
Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oroph
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
Z-1628-2018 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
10 clearances for this product code
- Dualams, Inc., Dba AirkorOct 16, 2024
K240114 · UltraEzAir® (UEA1A)
- Medica Holdings, LLCApr 6, 2018
K172956 · Medicant Mucosal Atomizer
- Teleflex MedicalAug 19, 2016
K153470 · MADgic Laryngo-Tracheal Mucosal Atomization Device
- N.M. Beale Co., Inc.Mar 4, 2011
K093584 · EZ-MISTER
- Sharn, Inc.Jun 21, 2007
K070596 · TOPICAL APPLICATOR
- Wolfe Tory Medical, Inc.Sep 18, 2000
K002255 · LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)
- Astra Pharmaceutical Products, Inc.Jan 12, 1990
K894755 · ASTRA DISPOSABLE SPRAY CANNULA
- Ackrad LaboratoriesFeb 26, 1981
K810059 · ENDO-MED TUBE FOR ENDOTRACHEAL MED