125 results
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16ms
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Sources: EU EUDAMED, US FDA
reSET-O Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
FDA Recall
Terminated
·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021
reSET Mobile App, iOS and Android, provides cognitive behavioral therapy, as part of substance abuse treatment.
FDA Recall
Terminated
·Pear Therapeutics, Inc.·Product code PWE·June 7, 2021
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fluid management and renal replacement therapies.
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDI·July 22, 2021
VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. Anesthesiology: This device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilatory support.
FDA Recall
Terminated
·Vortran Medical Technology 1, Inc·Product code BTL·April 20, 2017
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative) The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C, The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous (AV) fistulae and synthetic dialysis grafts.
FDA Recall
Terminated
·TELEFLEX MEDICAL INC·Product code QEW·January 11, 2022
St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102, Alameda, CA 94501
FDA Recall
Terminated
·St. Francis Medical Technologies Inc·Product code NQO·June 6, 2006
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
FDA Recall
Terminated
·TEM Systems Inc·Product code JPA·October 23, 2014
Wave Prep Tubes (1710-03) and single use cups (17--00-24)
FDA Recall
Terminated
·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019
PediaPrep Tubes (MD0033-T) and Single use cups (MD0033-SUP)
FDA Recall
Terminated
·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019
MVAP MEDICAL SUPPLIES INC, Mavidon CardioPrep Single, 24 use cups, Re order # MCP-24
FDA Recall
Terminated
·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019
LemonPrep Tubes (MD0019-T) and Single use cups (MD0019-SUP)
FDA Recall
Terminated
·Carroll-Baccari, Inc.·Product code KOY·December 23, 2019
Hamamatsu model L10951-35 Micro Focus x-ray generator. The x-ray generator is incorporated into a cabinet x-ray system that is used for a variety of studies.
FDA Recall
Terminated
·Hamamatsu Corporation·Product code RBS·July 7, 2011
Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019
Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
FDA Recall
Terminated
·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019