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PRECISION MEDICAL, INC.

United States·US-MF-000008706

Last updated September 17, 2026

Information

Country
United States
Address
300, Held Drive, Northampton, United States
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
Brian Klotz
EUDAMED SRN
US-MF-000008706
FDA FEI Number
2523148
DUNS Number
—

Catalogue (196)

Page 2 of 4
DeviceModel / ReferenceRegistriesClassStatus
Precision Medical PMX3400
FDA UDI
Class IIActive
Precision Medical Inc. PM3100 SERIES
FDA UDI
Class IIActive
Easy Dial Reg 1654 Dial Series
FDA UDI
Class IActive
Precision Medical Inc. PM3100HV SERIES
FDA UDI
Class IIActive
Precision Medical Inc. PM3000HV SERIES
FDA UDI
Class IIActive
Precision Medical Inc 1MFA Series Oxygen Flowmeter - TriTech Medical Inc.
FDA UDI
Class IActive
Vacuum Regulator PM3600D series w/ Vac Trap
FDA UDI
Class IIActive
1MFA Flowmeters 1MFA9001AM
FDA UDI
Class IUnknown
8MFA Flowmeters 8MFA6000 SERIES
FDA UDI
Class IActive
Vacuum Regulator PS3300 series w/ Vac Trap
FDA UDI
Class IIActive
Vacuum Regulator PS300DHV SERIES w/ Vac Trap
FDA UDI
Class IIActive
Vacuum Regulator PM3000HV series w/PM9100
FDA UDI
Class IIActive
Easy Gauge Regulator 1654 Gauge Series
FDA UDI
Class IActive
1MFA Flowmeters Y1MFAPCFP
FDA UDI
Class IActive
Easy Pulse II Oxygen Conserver 198705OG
FDA UDI
Class IIActive
PRECISION ECO™ Plant Based Procedural Mask with Earloops CK005
FDA UDI
Class IIActive
Power Vac Aspirator PM61CE
FDA UDI
Class IIActive
Vacuum Regulator PS3600D
FDA UDI
Class IIUnknown
Vacuum Regulator PM3100DHV series w/ Vac Trap
FDA UDI
Class IIActive
HeliO2 Blender PM5470
FDA UDI
Class IIActive
Vacuum Regulator PM3300DHV series w/ Vac Trap
FDA UDI
Class IIActive
Dial Flowmeter 7MFA Air SERIES
FDA UDI
Class IActive
Vacuum Regulator PM3300 series w/ PM9100
FDA UDI
Class IIActive
Precision Medical PMX901
FDA UDI
Class IIActive
Vacuum Regulator PM3600 series w/ Vac Trap
FDA UDI
Class IIActive
Precision Medical Inc. PM3300
FDA UDI
Class IIActive
8MFA Flowmeters 8MFA7000 SERIES
FDA UDI
Class IActive
Vacuum Regulator PM3600DBM
FDA UDI
Class IIUnknown
Precision Medical Inc. PM60
FDA UDI
Class IIActive
Vacuum Regulator PS3300HV series w/ Vac Trap
FDA UDI
Class IIActive
Precision Medical PM60E
FDA UDI
Class IIActive
Vacuum Regulator PS3300DHV SERIES
FDA UDI
Class IIActive
Precision Medical PSX3600
FDA UDI
Class IIActive
1MFA Flowmeters 1MFA6000 SERIES
FDA UDI
Class IActive
Precision Medical Inc. PM3400 SERIES
FDA UDI
Class IIActive
Precision Medical PMX3600D
FDA UDI
Class IIActive
Easy Pulse 5 Oxygen Conserving Regulator 1900 SERIES
FDA UDI
Class IIActive
Vacuum Regulator PM3300D SERIES
FDA UDI
Class IIActive
Precision Medical Inc. PS3000 SERIES
FDA UDI
Class IIActive
PRECISION ECO™ Plant Based Procedural Mask with Earloops CS001
FDA UDI
Class IIActive
Precision Medical Inc. PS3300 SERIES
FDA UDI
Class IIActive
Precision Medical PMX3300DHV
FDA UDI
Class IIActive
Precision Medical Inc. 504877-
FDA UDI
Class IIActive
Precision Medical Inc. PS3300D SERIES
FDA UDI
Class IIActive
Precision Medical Inc. PS3300HV SERIES
FDA UDI
Class IIActive
Vacuum Regulator PM3000 series w/Vac Trap
FDA UDI
Class IIActive
Vacuum Regulator PS3500D
FDA UDI
Class IIUnknown
Vacuum Regulator PM3100DHV SERIES
FDA UDI
Class IIActive
Precision Medical PMX3100HV
FDA UDI
Class IIActive
Precision Medical PMX3000
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Oct 8, 2015Z-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, 2010Z-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, 2006Z-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, 2004Z-0307-05—terminated

Battery charger can be overcharged and overheat

Nov 9, 2004Z-0308-05—terminated

Battery charger can be overcharged and overheat