1,033 results · 21ms · Sources: EU EUDAMED, US FDA

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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