1,033 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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AC Powered hospital adjustable bed.
FDA Recall
Terminated
·Umano Medical, Inc.·Product code FNL·May 4, 2020
CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
FDA Recall
Terminated
·Zeltiq Aesthetics, Inc·Product code OOK·July 5, 2021
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
FDA Enforcement
Class II
·Terminated·Cook Inc.·December 21, 2016
Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 25, 2018
Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
FDA Enforcement
Class II
·Terminated·Cook Inc.·April 25, 2018
LOCIQ Book System models: 2399921, 2399923, 2349933, 2349934 and 2349935
FDA Recall
Terminated
·General Electric Med Systems LLC·Product code IYN·September 2, 2004
Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight catheter, for cardiovascular use.
FDA Enforcement
Class II
·Terminated·Cook Inc.·November 18, 2015
UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous tract.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 30, 2016
Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set consists of a radiopaque balloon catheter and inflation device. The Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set is used for transluminal dilation of ureteral strictures or ureteral dilation prior to ureteroscopy and stone manipulation.
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 30, 2016
Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
FDA Enforcement
Class II
·Terminated·Cook Inc.·June 21, 2017
COOK MEDICAL Captura SERRATED LARGE FORCEP-NO SPIKE, 2.4 mm, 230 cm, DBF-2.4SL- 230-20-S
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·February 6, 2019
COOK MEDICAL Captura SERRATED BIOPSY FORCEPS WITH SPIKE,2.4 mm, 230 cm, with Spike, DBF-2.4SN-230SP-20-S
FDA Enforcement
Class II
·Terminated·Wilson-Cook Medical Inc.·February 6, 2019
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
FDA Enforcement
Class I
·Terminated·Cook Inc.·March 20, 2019
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 7, 2018
Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 7, 2018
Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
FDA Enforcement
Class II
·Terminated·Cook Inc.·March 7, 2018
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
FDA Enforcement
Class II
·Terminated·Cook Inc.·May 29, 2019
Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder
FDA Enforcement
Class II
·Terminated·Cook Inc.·September 23, 2020
Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/12cm, CUTLMY501JRSCCCT, G26945, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010
Cook Central Venous Catheter Tray, Triple Lumen Polyurethane, 5.0Fr/15cm, CUTLMY501JLSCCCT, G26943, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.
FDA Recall
Terminated
·Cook, Inc.·Product code FOZ·October 4, 2010