34 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006
FDA Recall
Terminated
·Synapse Biomedical Inc·Product code OIR·May 31, 2022
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
FDA Recall
Terminated
·Synapse Biomedical Inc·Product code OIR·July 11, 2022
Plasma Pump Model PP-04a Used with Asahi Plasmaflo Plasma Separators and plasma exchange tubesets to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·July 9, 2012
Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. Apheresis Technologies, Inc. Palm Harbor, FL. - No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·April 1, 2009
American Diagnostica Inc. ACTICLOT dPT Reference 824 in vitro diagnostic
FDA Recall
Terminated
·American Diagnostica, Inc.·Product code GIR·February 28, 2007
PlasmaPrO" Plasma Pump Model PP-05 Product Usage: The PlasmaPro Plasma Pump is a pump to be used with Asahi Plasma Separators to perform therapeutic plasma exchange.
FDA Recall
Terminated
·Apheresis Technologies, Inc.·Product code FIR·November 29, 2010
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
FDA Enforcement
Class II
·Terminated·Bien Air Dental SA·September 30, 2015
JK Bariatric Beds, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code OSI·March 18, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Recall
Terminated
·SCM True Air Technologies LLC·Product code FNM·March 18, 2014
JK Bariatric Beds, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
FDA Enforcement
Class II
·Terminated·SCM True Air Technologies LLC·May 28, 2014
ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
FDA Recall
Terminated
·Extended Care Air Therapy Systems Inc·Product code FNL·April 5, 2006
Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used for generally dentistry procedures
FDA Recall
Terminated
·Bien Air Dental SA Langgasse 60 Biel/bienne Switzerland·Product code EGS·August 27, 2015
BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermenting and nonfermenting gram-negative bacilli.
FDA Recall
Terminated
·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSS·May 21, 2014
Trypticase TM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar Cat. Number 221291, Lot Number 6034889, Exp. Date : April 20, 2016 Product is sold in cartons of 100 plates each. Product Usage: Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
FDA Recall
Terminated
·Becton Dickinson & Co. 7 Loveton Cir BD Diagnostic Systems·Product code JSI·March 28, 2016
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·February 5, 2018
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
FDA Recall
Terminated
·Hyphen BioMed 155 rue d Eragny Neuville Sur Oise France·Product code LCO·November 9, 2011