Panels › Anesthesiology › Product code CCT · Class 2
Applicator (Laryngo-Tracheal), Topical Anesthesia
Regulation 868.5170
0510(k)s in 12 months (10 all time)
0recalls in 12 months (6 all time)
5recalls that name a 510(k)
Top companies in CCT
| Company | 510(k)s | Recalls |
|---|---|---|
| Sharn, Inc. | 1 | 3 |
| Teleflex Medical | 1 | 2 |
| Sherwood Medical Industries | 2 | 0 |
| Ackrad Laboratories | 1 | 0 |
| Astra Pharmaceutical Products, Inc. | 1 | 0 |
| Dualams, Inc., Dba Airkor | 1 | 0 |
| Medica Holdings, LLC | 1 | 0 |
| N.M. Beale Co., Inc. | 1 | 0 |
| Teleflex Medical Europe Ltd | 0 | 1 |
| Wolfe Tory Medical, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2018 | Teleflex Medical Europe Ltd Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region Terminated |
CCT | None listed |
| Aug 25, 2017 | Teleflex Medical LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c)
MAD720 MADgic
Intended for the application of topical anesthetics to the oropharynx and u Terminated |
CCT | K153470 |
| Nov 9, 2016 | Teleflex Medical LMA MADgic, Atomization Device with 3mL Syringe, Rx only,
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryng Terminated |
CCT | K153470 |
| Nov 16, 2009 | Sharn, Inc. Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
REF: LTAD-N3-25, Lot 121608, packed 25 per package.
REF: LTAD-N3-1 Terminated |
CCT | K070596 |
| Nov 16, 2009 | Sharn, Inc. Nasal Mucosal Atomizer Device with syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
REF: LTAD-N1-25, Lot 121608, packed 25 per package.
REF: LTAD-N1-100, Terminated |
CCT | K070596 |
| Nov 16, 2009 | Sharn, Inc. Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA.
REF: LTAD-PL7-25, Lot 121508, packed 25 per packag Terminated |
CCT | K070596 |
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