Panels › Anesthesiology › Product code CCQ · Class 1
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Regulation 868.5640
0510(k)s in 12 months (62 all time)
0recalls in 12 months (9 all time)
2recalls that name a 510(k)
Top companies in CCQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Armour Pharmaceutical Co. | 5 | 0 |
| Teleflex Medical | 0 | 5 |
| Monaghan Medical Corp. | 3 | 0 |
| Nephron Pharmaceuticals Corp. | 0 | 3 |
| Vortran Medical Technology 1, Inc. | 3 | 0 |
| The Devilbiss Co. | 2 | 0 |
| Devilbiss Health Care, Inc. | 2 | 0 |
| Dey Laboratories, Inc. | 2 | 0 |
| Dhd Medical Products Div. Diemolding Corp. | 2 | 0 |
| Key Pharmaceuticals, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2016 | Teleflex Medical Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, M Terminated |
CCQ | None listed |
| Nov 9, 2016 | Teleflex Medical LMA MADdy, Rx only,
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recall Terminated |
CCQ | None listed |
| Nov 9, 2016 | Teleflex Medical FLEXI NOZZLE SHORT
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recallin Terminated |
CCQ | K153470 |
| Nov 9, 2016 | Teleflex Medical FLEXI NOZZLE LONG, 10 Boxes of 25 units each
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Te Terminated |
CCQ | None listed |
| Nov 9, 2016 | Teleflex Medical LMA MADomizer, Rx only,
Product Usage:
These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is re Terminated |
CCQ | None listed |
| May 29, 2013 | Nephron Pharmaceuticals Corp. EZ Breathe Medication Cup.
For the delivery of liquid medications for respiratory usage. Terminated |
CCQ | None listed |
| May 29, 2013 | Nephron Pharmaceuticals Corp. AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer.
For the delivery of liquid medications for respiratory usage. Terminated |
CCQ | None listed |
| May 29, 2013 | Nephron Pharmaceuticals Corp. EZ Breathe Atomizer Model # EZ-100.
For the delivery of liquid medications for respiratory usage. Terminated |
CCQ | None listed |
| Oct 26, 2011 | Salter Laboratories, Division of Regulatory Affairs Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free
Salter Labs, Arvin, CA 93203
Intended usage: respiratory therapy. Terminated |
CCQ | K870027 |
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