128 results
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32ms
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Sources: EU EUDAMED, US FDA
AIRIVER MEDICAL
FDA registration
AIRIVER MEDICAL·1 product·🇺🇸 United States
INFUSOMAT®
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code FPA·March 19, 2024
Bongo Rx
FDA UDI
AirAvant Medical·10833224005004·Bongo Rx - Four Sizes Kit (includes 1 each of s...
Bongo Rx
FDA UDI
AirAvant Medical·10833224005028·Bongo Rx - SM - 4 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005158·Bongo Rx - XL - 1 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005059·Bongo Rx - XL - 4 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005110·Bongo Rx - XS - 1 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005141·Bongo Rx - LG - 1 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005035·Bongo Rx - MD - 4 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005127·Bongo Rx - SM - 1 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005134·Bongo Rx - MD - 1 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005042·Bongo Rx - LG - 4 Pack
Bongo Rx
FDA UDI
AirAvant Medical·10833224005011·Bongo Rx - XS - 4 Pack
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The Spectrum and Spectrum with MAster Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·May 16, 2018
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FDA Adverse Event
MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING·Product code ITJ·January 26, 2012
WALKER
FDA Adverse Event
Malfunction
·MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING·Product code ITJ·September 15, 2015
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FDA Adverse Event
MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING·Product code ILS·January 12, 2015
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FDA Adverse Event
Malfunction
·MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING·Product code ITJ·June 17, 2015
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FDA Adverse Event
Malfunction
·MEDICAL DEPOT D/B/A DRIVE MEDICAL DESIGN AND MANUFACTURING·Product code ITJ·June 18, 2015