455 results
·
13ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
×
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·December 29, 2017
INFX-8000V Fluoroscopic X-Ray Systems; INFINIX CF-I/BP PLUS CARDIAC SYSTEM
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·March 14, 2018
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 15, 2015
FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 Intended use: Intravascular Administration Set
FDA Recall
Terminated
·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010
Sterile, Drape, Headset, Lower, Part Number 888944-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
Sterile, Drape, Headset, Upper, Part Number 888945-01.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is registered as lnfinix CF-i or lnfinix VF-i, for national regulations. INFX-8000V series includes a floor mounted multi-axis positioner.
FDA Recall
Terminated
·Toshiba American Medical Systems Inc·Product code OWB·March 11, 2015
Disposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
GE Medical Systems, OEC, Vascular Drape, 00-902776-01, Sterile. 150" long x 87" wide. Distributed by GE OEC Medical Systems, Salt Lake City, UT 84116 USA.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 15, 2008
TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
FDA Recall
Terminated
·Cardiac Assist, Inc·Product code DWF·December 2, 2010
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGA·February 25, 2013
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
FDA Recall
Terminated
·Nova Biomedical Corporation·Product code CGA·February 25, 2013
GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
FDA Recall
Terminated
·GE Medical Systems, LLC·Product code MMP·August 29, 2008
Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·September 24, 2012
Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INN·April 2, 2015
Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380000-2 (gray). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Models 394000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare Recliner 5400***Winco***ISO 9001 2008 Certified***Key Features***Urethane armrests***Fully upholstered***Multiple side-table Options***3-position lockbar*** "No pinch" safety zone***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA.***" Press on type label: "***Manufactured By Winco Ocala, FL 34474***Model No. 540***Serial No. 540-...***" Press on type label: "***Model No. 557-...***Serial No.***". Long-term multi-positional recliner.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·October 17, 2011