Company ยท US
Monaghan Medical Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2023. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BZH | Meter, Peak Flow, Spirometry | 10 |
| CAF | Nebulizer (Direct Patient Interface) | 5 |
| BYP | Mouthpiece, Breathing | 3 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 3 |
| FFK | Lithotriptor, Electro-Hydraulic | 3 |
| BWF | Spirometer, Therapeutic (Incentive) | 2 |
| BZQ | Monitor, Breathing Frequency | 2 |
| CBK | Ventilator, Continuous, Facility Use | 2 |
| BZA | Connector, Airway (Extension) | 1 |
| BZK | Spirometer, Monitoring (W/Wo Alarm) | 1 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| CAZ | Anesthesia Conduction Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2023 | K220145 | Monaghan medical filtered mouthpiece kit Monaghan Medical Corporation | CAF |
| Apr 17, 2013 | K123945 | STRIVE DUAL ZONE PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Jun 9, 2011 | K110273 | AEROVENT PLUS CHC Monaghan Medical Corporation | CAF |
| May 23, 2003 | K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Mar 7, 2003 | K023097 | TRUEZONE PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Sep 28, 2001 | K012939 | AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER Monaghan Medical Corp. | CAF |
| Jul 1, 1999 | K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Jan 10, 1997 | K964130 | AEROGEAR ASTHMA ACTION KIT Monaghan Medical Corp. | BZH |
| Nov 6, 1996 | K963089 | TRUZONE PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Nov 4, 1996 | K963095 | TRUPEAK PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Mar 18, 1996 | K955234 | TRUPEAK PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Mar 7, 1996 | K955262 | TRUZONE PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Nov 2, 1994 | K944512 | TRUZONE PFM DISPOSABLE MOUTHPIECE Monaghan Medical Corp. | BYP |
| Jan 24, 1994 | K930574 | AEROCHAMBER W/MASK, MODIFIED Monaghan Medical Corp. | CAF |
| Jul 22, 1993 | K926307 | PEAK FLOW METER Monaghan Medical Corp. | BZH |
| Aug 19, 1991 | K911263 | 22MM ID/OD ADAPTER Monaghan Medical Corp. | CAI |
| May 13, 1991 | K900576 | MODIFIED AEROCHAMBER WITH MASK Monaghan Medical Corp. | CCQ |
| Apr 10, 1991 | K900557 | MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER Monaghan Medical Corp. | CCQ |
| Mar 12, 1991 | K910138 | TVS II ELECTRONIC INCENTIVE SPIROMETER Monaghan Medical Corp. | BWF |
| Mar 12, 1990 | K884389 | MODIFIED 225/SIMV VOLUME VENTILATOR Monaghan Medical Corp. | CBK |
| Oct 30, 1989 | K894969 | AEROVENT Monaghan Medical Corp. | BZA |
| Jun 7, 1989 | K884942 | MONAGHAN RVM, MODEL 761 Monaghan Medical Corp. | BZK |
| Apr 26, 1989 | K884803 | AEROCHAMBER M.V. Monaghan Medical Corp. | CAF |
| Dec 30, 1987 | K874513 | MONAGHAN AEROCHAMBER WITH MASK Monaghan Medical Corp. | CCQ |
| Jul 24, 1987 | K872037 | AEROCHAMBER Monaghan Medical Corp. | BYP |
| Oct 15, 1986 | K863612 | MONAGHAN RVM, MODEL 760 AND 761 Monaghan Medical Corp. | BZQ |
| Nov 18, 1985 | K853047 | MONAGHAN RVM, MODEL 760 OR MODEL 761 Monaghan Medical Corp. | BZQ |
| May 25, 1984 | K834228 | LITHOTRIPTOR ELECTRODE 4.5F Monaghan Medical Corp. | FFK |
| Feb 9, 1983 | K830086 | 4.5 F LITHOTRIPTOR ELECTRODE Monaghan Medical Corp. | FFK |
| Nov 16, 1982 | K822635 | 225 S.I.M.V. VENTILATOR Monaghan Medical Corp. | CBK |
| Nov 3, 1982 | K822437 | MONAGHAN AEROCHAMBER Monaghan Medical Corp. | BYP |
| Sep 28, 1982 | K822585 | LITHOTRIPTOR ELECTRODE 4.5F Monaghan Medical Corp. | FFK |
| Aug 5, 1982 | K821649 | MONAGHAN'S PRESSURE ALARM Monaghan Medical Corp. | CAP |
| Mar 23, 1982 | K820606 | MONAGHAN'S TRUE VOLUME EXERCISER Monaghan Medical Corp. | BWF |
| Aug 11, 1976 | K760352 | CIRCUIT, INTENSIVE CARE VENTILATOR Monaghan Medical Corp. | CAZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||