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Sign in to claim this brandPRECISION MEDICAL, INC.
United States·US-MF-000008706
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 300, Held Drive, Northampton, United States
- Website
- precisionmedical.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Brian Klotz
- EUDAMED SRN
- US-MF-000008706
- FDA FEI Number
- 2523148
- DUNS Number
- —
Catalogue (196)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Precision Medical Inc. | PS3100HV SERIES | FDA UDI | Class II | Active |
| Precision Medical | PMX3300 | FDA UDI | Class II | Active |
| Vacuum Regulator | PM3100HV series w/ PM9100 | FDA UDI | Class II | Active |
| Vacuum Regulator | PM3000 series w/PM9100 | FDA UDI | Class II | Active |
| Vacuum Regulator | PM3400D series w/ Vac Trap | FDA UDI | Class II | Active |
| EasyPulse TOC | PM4400 | FDA UDI | Class II | Unknown |
| Easy Gauge Reg | 1687 Gauge Series | FDA UDI | Class I | Active |
| Live Active Five | PM4155 | EUDAMEDFDA UDI | Class IIa | Active |
| PM5200 Air/Oxygen Blender (High Flow) | Air/Oxygen Blender (High Flow) | EUDAMEDFDA UDI | Class IIb | Active |
| Pm Pump Aspirator | K932494 | FDA 510(k) | Class II | Active |
| Select Flowmeter | K854067 | FDA 510(k) | Class I | Active |
| Flowmeter, Backpressure Compensated, Thorpe Tube | K850560 | FDA 510(k) | Class I | Active |
| Minimate Compressor | K051691 | FDA 510(k) | Class II | Active |
| Pm3300 Intermittent Vacuum | K944479 | FDA 510(k) | Class II | Active |
| Pm14 Soft Air Compressor | K902762 | FDA 510(k) | Class II | Active |
| Helio2 Blender | K090781 | FDA 510(k) | Class II | Active |
| Pm3000 & Pm3100 Vacuum Regulator | K922817 | FDA 510(k) | Class II | Active |
| Precision Liquid Oxygen System | K103324 | FDA 510(k) | Class II | Active |
| Flow Controller | K843223 | FDA 510(k) | Class II | Active |
| Precision Portable Oxygen Concentration Model 4150 | K103563 | FDA 510(k) | Class II | Active |
| Pm 1800 Conserving Device | K001412 | FDA 510(k) | Class II | Active |
| Easy Pulse Ii Oxygen Conserver | K032018 | FDA 510(k) | Class II | Active |
| 1500 Series Regulator | K932006 | FDA 510(k) | Class I | Active |
| Pm Pump Compressor | K930509 | FDA 510(k) | Class II | Active |
| Precision Medical Disposable Humidifier | K902970 | FDA 510(k) | Class II | Active |
| Easy Go Vac | K140179 | FDA 510(k) | Class II | Active |
| Precision Medical Eliminator | K902917 | FDA 510(k) | Class I | Active |
| Precision Medical Neb Block | K902916 | FDA 510(k) | Class I | Active |
| Pressure Relief Adaptor | K850559 | FDA 510(k) | Class I | Active |
| Pm9000 Vac Trap | K941818 | FDA 510(k) | Class II | Active |
| Precision Liquid Oxygen System | K041122 | FDA 510(k) | Class II | Active |
| Precision Oxygen Monitor | K063096 | FDA 510(k) | Class II | Active |
| Carepak | K942350 | FDA 510(k) | Class II | Active |
| Accu O2 Oxygen Analyzer | K173807 | FDA 510(k) | Class II | Active |
| Easygo Aspirator | K971749 | FDA 510(k) | Class II | Active |
| Precision Medical Oxygen Regulator | K901831 | FDA 510(k) | Class I | Active |
| Precision Mist Compressor | K923324 | FDA 510(k) | Class II | Active |
| Precision Oxygen Concentrator | K072348 | FDA 510(k) | Class II | Active |
| 8mfa Series Flowmeters (air) | 8MFA SERIES FLOWMETERS (AIR) | EUDAMEDFDA UDI | Class IIa | Active |
| 1mfa Series Flowmeters (oxygen | 1MFA Series Flowmeter | EUDAMEDFDA UDI | Class IIa | Active |
| PM5300 Series Blender, Air/O2, Low Flow | PM5300 Series Blender, Air/O2, Low Flow | EUDAMEDFDA UDI | Class IIb | Active |
| 1MFA Air Series | 1MFA SERIES FLOWMETERS (AIR) | EUDAMEDFDA UDI | Class IIa | Active |
| 6mfa Series Flowmeters | 6MFA SERIES FLOWMETERS | EUDAMEDFDA UDI | Class IIa | Active |
| 8mfa Series Flowmeters (oxygen) | 8MFA SERIES FLOWMETERS (OXYGEN) | EUDAMEDFDA UDI | Class IIa | Active |
| 4mfa Series Flowmeters | 4MFA SERIES FLOWMETERS | EUDAMEDFDA UDI | Class IIa | Active |
| 3MFA Series Flowmeter | 3MFA Series Flowmeter | EUDAMEDFDA UDI | Class IIa | Active |
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 8, 2015 | Z-0272-2016 | — | terminated | These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25). |
| Mar 5, 2010 | Z-1561-2010 | — | terminated | The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off" |
| Oct 4, 2006 | Z-0153-2007 | — | terminated | Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents. |
| Nov 9, 2004 | Z-0307-05 | — | terminated | Battery charger can be overcharged and overheat |
| Nov 9, 2004 | Z-0308-05 | — | terminated | Battery charger can be overcharged and overheat |