26 results
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28ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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UROVAL INC/FOLKERTS
FDA registration
UROVAL INC/FOLKERTS·2 products·🇺🇸 United States
Uroval
FDA UDI
UROVAL, INC.·00852523007024·6' Electrode Lead Wire Set for use with the Ur...
Uroval
FDA UDI
UROVAL, INC.·00852523007062·The Uroval BRS System is used to record and dis...
URO-1, INC.
FDA registration
URO-1, INC.·3 products·🇺🇸 United States
BRIGHT URO, INC.
FDA registration
BRIGHT URO, INC.·2 products·🇺🇸 United States
Glean
FDA UDI
Bright Uro, Inc·00860009800632·Glean Uroflowmeter Charging Puck
Glean
FDA UDI
Bright Uro, Inc·00860009800656·Glean Sensor with Female Insertion Tool
Glean
FDA UDI
Bright Uro, Inc·00086000980061·Glean Sensor with Female Insertion Tool 5 Pack
URO Saf-Gard Extension Tubing
FDA UDI
URO CONCEPTS INC·00868636000418·48 “Tubing Length
Glean
FDA UDI
Bright Uro, Inc·00860009800625·Glean Uroflowmeter
URO Saf-Gard Extension Tubing
FDA UDI
URO CONCEPTS INC·00868636000401·18 “Tubing
Glean
FDA UDI
Bright Uro, Inc·00860009800649·Glean Sensor with Male Insertion Tool
Glean
FDA UDI
Bright Uro, Inc·00860009800601·Glean Sensor with Male Insertion Tool 5 Pack
AVAULTA PLUS POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM
FDA Adverse Event
Injury
·BARD UROGICAL, C.R. BARD, INC·Product code FTL·July 17, 2008
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
FDA Enforcement
Class II
·Terminated·Hospira Inc.·January 9, 2013
Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software; Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Enforcement
Class II
·Terminated·Hospira Inc.·January 9, 2013
URINARY CATHETER
FDA Adverse Event
Injury
·BARD UROL DIV. C.R. BARD, INC.·Product code KOD·July 19, 1996
Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version 11.3; d) list 20679 - Hospira MedNet Software e) list 20792 - Hospira MedNet Software; Product Usage: The Plum A+ Infusion System is a dual-line volumetric infusion pump that provides precise delivery of multiple i.v. therapies across the general spectrum of clinical care, including ICU/CCU, OR, PACU, ER, Med/Surg, Pediatrics, Outpatient clinics and Home care
FDA Enforcement
Class II
·Terminated·Hospira Inc.·January 9, 2013
Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
FDA Recall
Terminated
·Penumbra Inc.·Product code DQY·September 22, 2009
Plum A+ Hyperbaric Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; list number 11005 Product Usage: The Plum A+ Hyperbaric Infusion System is exclusively designed for hyperbaric therapy in monospace and multiplace chambers.
FDA Recall
Terminated
·Hospira Inc.·Product code FRN·December 7, 2012