561 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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PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·October 15, 2014
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
FDA Enforcement
Class II
·Terminated·Navilyst Medical, Inc·October 15, 2014
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 5F-55 cm SINGLE LUMEN, UPN Product No. H96560M1406071, REF/Catalog No. 60M140607, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJS·August 25, 2014
PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code LJS·August 25, 2014
Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601
FDA Recall
Terminated
·Medibo N.V. Heikant 5 Hanmont, Achel Belgium·Product code FSA·August 4, 2004
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
FDA Enforcement
Class II
·Terminated·Biosense Webster, Inc.·September 21, 2016
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
FDA Enforcement
Class II
·Terminated·Angiodynamics Inc. (Navilyst Medical Inc.)·February 15, 2017
NAMIC (TM) Convenience Kit --- Legal Manufacturer Navilyst Medical, Inc, 26 Forest St, Marlborough, MA 01752 USA --- Made in USA: 10 Glen Falls Technical Park, Glen Falls, NY 12801 USA --- each unit label contains the customer name under the name of the product, and each catalog number is specific to the customer. Product usage: For use in fluid management and/or invasive pressure monitoring systems
FDA Recall
Terminated
·Navilyst Medical, Inc·Product code OEZ·December 19, 2011
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia device used to lower or to raise a patients temperature and/or maintain a desired patient temperature through conductive heat transfer.
FDA Enforcement
Class II
·Terminated·Cincinnati Sub-Zero Products Inc·September 25, 2013
Hydration Station with Pedestal (Part # E30003-01), Hydration Station with Pedestal & DVD (Part # E30003-01D), Sybaritic, Inc., 9229 James Avenue South, Minneapolis, MN 55431.
FDA Recall
Terminated
·Sybaritic, Inc·Product code IMB·May 15, 2007
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.
FDA Recall
Terminated
·Spacelabs Healthcare Inc·Product code MHX·May 8, 2015
ETI-AB-AUK PLUS kits,REF P001931, DiaSorin S.p.A., 13040 Saluggia (VC), Italy, Distributed by: DiaSorin Inc., 1951 Northwestern Avenue, P.O. Box 285, Stillwater, MN 55082-0285 In vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma.
FDA Recall
Terminated
·Diasorin Inc.·Product code LOM·August 19, 2010
BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code MWI·June 5, 2007
BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DQA·July 18, 2007
Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
FDA Recall
Terminated
·Angiodynamics Inc. (Navilyst Medical Inc.)·Product code LJW·September 7, 2016
Pointe Scientific Uric Acid (Liquid) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU782-246 and HU982-615. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
Pointe Scientific Liquid Uric Acid (R1) Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # HU482-R1. For the quantitative determination of uric acid in serum on Hitachi analyzers. For in-vitro diagnostic use only.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code KNK·December 1, 2009
VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
FDA Recall
Terminated
·Remel Inc·Product code MDB·May 19, 2015
VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
FDA Recall
Terminated
·Remel Inc·Product code MDB·May 19, 2015
BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,
FDA Recall
Terminated
·Smiths Medical PM, Inc.·Product code DXN·April 2, 2008