121 results
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9ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.
FDA Enforcement
Class II
·Terminated·Hitachi Medical Systems America Inc·March 31, 2021
16 G / 5F Dual Lumen L-Cath complete kit with U-Wing
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
16 G / 5F Dual Lumen L-Cath Basic Kit with U-Wing
FDA Recall
Terminated
·Becton Dickinson Medical Systems·Product code LJS·March 25, 2005
DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
FDA Enforcement
Class II
·Terminated·Express Diagnostics Int'l., Inc.·February 11, 2015
ReTurn 7500/7500 Aid, transfer
FDA Enforcement
Class II
·Terminated·Handicare USA, Inc.·November 2, 2016
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
DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.
FDA Recall
Terminated
·Express Diagnostics Int'l., Inc.·Product code MGX·November 21, 2014
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
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
FDA Enforcement
Class II
·Terminated·Insulet Corporation·March 17, 2021
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