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MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT

FDA 510(k)
FDA Class 1 ·Anesthesiology

entre

FDA UDI
Tactile Systems Technology, Inc.·00816305020021·Entré/Entre Plus Long Arm - PD08-U

entre

FDA UDI
Tactile Systems Technology, Inc.·00816305020076·Entré/Entre Plus Extender, Long Full Leg PD08-U

entre

FDA UDI
Tactile Systems Technology, Inc.·00816305020052·

entre

FDA UDI
Tactile Systems Technology, Inc.·00816305023329·

entre

FDA UDI
Tactile Systems Technology, Inc.·00816305021639·

entre

FDA UDI
Tactile Systems Technology, Inc.·00816305021615·

EASY LOA INSERTER

FDA Adverse Event
Injury ·BAUSCH & LOMB, INC.·Product code MSS·June 23, 2009

EASY LOAS INSERTER

FDA Adverse Event
Injury ·BAUSCH & LOMB·Product code KYB·November 16, 2007

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 11, 2025

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·December 26, 2025

NIC-CARTRIDGE

FDA Adverse Event
Malfunction ·MAUNA LOA MEDICAL, INC.·Product code BZO·February 7, 1995

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·February 17, 2026

MAUNA LOA LAVABED 2

FDA Adverse Event
Injury ·OWENS-BRIGAM MEDICAL CO.·Product code BTT·May 6, 1998

TURNPIKE LP

FDA Adverse Event
Injury ·VASCULAR SOLUTIONS, INC.·Product code DQY·April 13, 2018

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·November 28, 2025

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·April 24, 2026

BD PYXIS¿ ES SERVER

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·February 18, 2026

BD PYXIS¿ MEDSTATION¿ ES

FDA Adverse Event
Malfunction ·CAREFUSION 303, INC.·Product code BRY·August 1, 2025

TRUERESULT

FDA Adverse Event
Malfunction ·NIPRO DIAGNOSTICS, INC.·Product code NBW·March 24, 2014