4,092 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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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