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Western/Scott Fetzer

FDA UDI
Western Enterprises·B929MNR6000·NEXTGEN 3/4-16 CONN/ALUM/ASSY

Western/Scott Fetzer

FDA UDI
Western Enterprises·B929MNR8000·NEXTGEN NO ON-OFF VALVE W/AUX

KODAK MN-R 2000 CASSETTE

FDA 510(k)
FDA Class 2 ·Radiology

NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST

FDA 510(k)
FDA Class 2 ·Neurology

RHINO-BOARD MNR PROC. HAND TBL OVERSIZE BOX

FDA UDI
ALIMED, INC.·00733657240252·

NEUROMED OCTRODE MODEL MNR-88A-B-C NEUROSTIM REC

FDA 510(k)
FDA Class 2 ·Neurology

NEUROMED OCTRODE MODEL MNR-88 W/98 ADAPTER NEURO.

FDA 510(k)
FDA Class 2 ·Neurology

Flexitouch Plus

FDA UDI
Tactile Systems Technology, Inc.·00816305023817·Full Leg Medium Assembly, Narrow, Right

Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen.

FDA Enforcement
Class I ·Terminated·Western / Scott Fetzer Company·July 29, 2015

MEDFUSION 4000 SYRINGE INFUSION PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·October 27, 2023

8110 ALARIS SYRINGE PUMP

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·October 6, 2020

Flexitouch Plus

FDA UDI
Tactile Systems Technology, Inc.·00816305024180·Full Leg Medium Assembly, Narrow, Right (Demo S...

INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT

FDA Adverse Event
Injury ·ALLERGAN (COSTA RICA)·Product code FTR·January 21, 2021

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 30, 2020

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 21, 2020

MEDFUSION 3500 PUMP

FDA Adverse Event
Malfunction ·ST PAUL·Product code FRN·September 20, 2023

8015 ALARIS SYSTEM PC UNIT

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·November 2, 2020

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·October 13, 2020

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·December 4, 2020

8100 ALARIS PUMP MODULE

FDA Adverse Event
Malfunction ·CAREFUSION SD·Product code FRN·October 19, 2020