11 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
FDA Recall
Terminated
·Inovo, Inc·Product code CAW·July 21, 2016
Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.
FDA Recall
Terminated
·Inovo, Inc·Product code NFB·April 26, 2019
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
FDA Recall
Terminated
·Inovo, Inc·Product code CAW·October 9, 2017
INOVO Purefill Oxygen Compressor Model PF1100 Is an oxygen refill machine that you can attach to an oxygen concentrator to refill portable oxygen cylinders.
FDA Enforcement
Class II
·Terminated·Inovo, Inc·December 21, 2016
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
FDA Enforcement
Class II
·Terminated·Inovo, Inc·January 31, 2018
Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios.
FDA Enforcement
Class II
·Terminated·Inovo, Inc·August 7, 2019
Inova Diagnostics BINDAZYME Human C1q binding Circulating Immune Complex EIA Kit, Part#: MK021
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code DAK·October 28, 2009
Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.
FDA Recall
Terminated
·Inova Diagnostics Incorporated·Product code DHN·September 26, 2011
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
FDA Enforcement
Class I
·Terminated·Hospira Inc.·October 31, 2012
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural
FDA Enforcement
Class I
·Terminated·Hospira Inc.·October 31, 2012
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for single patient use by diabetics for the self injection of a desired dose of insulin. The pen injector uses Penfill 3 mL cartridge of NovoLog¿, 100 units/mL (Ux100) [insulin aspart (rDNA origin) injection] and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 0.5 to 30 units in 0.5 increments.
FDA Enforcement
Class II
·Terminated·Novo Nordisk Inc·December 13, 2017