31 results
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31ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, REF 000627, 20F.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, REF 000628, 20F.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008
Bard Access Systems, Inc., Ponsky* Deluxe "Pull" PEG (Percutaneous Endoscopic Gastrostomy) Kit with Soft Silicone Retention Dome, Sterile, Rx only, REF 000792, 20F.
FDA Recall
Terminated
·C.R. Bard Access Systems, Inc·Product code KNT·December 4, 2008
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
Medtronic Disposable Pressure Display Set, Models 61000, 61006, 62000, 62006. Sterilized by Ethylene Oxide. Non-pyrogenic. Coiled PVC tubing with threaded transducer dome (acrylic) with silicone diaphragm on proximal end. Product utilizes a stopcock on proximal and/or distal end. Distal end of tubing features a male luer port. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604. Product Usage: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
FDA Recall
Terminated
·Medtronic Perfusion Systems·Product code DXS·September 9, 2011
Omega Incline Platform Lift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
FDA Enforcement
Class II
·Terminated·California Medical Laboratories Inc·January 16, 2013
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.
FDA Recall
Terminated
·Medline Industries Inc·Product code IOR·March 31, 2008
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809700 comes with Removable Full-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable. item #MDS809750 comes with Removable Full-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.
FDA Recall
Terminated
·Medline Industries Inc·Product code IOR·March 31, 2008
Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809800 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Hemi-Height Adjustable. item #MDS809850 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Hemi-Height Adjustable.
FDA Recall
Terminated
·Medline Industries Inc·Product code IOR·March 31, 2008
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 1, 2012
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
FDA Enforcement
Class II
·Terminated·California Medical Laboratories Inc·January 16, 2013
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
Clarisonic Skin Care System - A hand held cleansing device for the skin. The Unit comes with a charger cradle for charging the device. Pacific Bioscience Laboratories, Inc., 13222 SE 30th St., Bellevue, WA 98005
FDA Recall
Terminated
·Pacific Bioscience Lab, Inc.·Product code FLG·July 3, 2007
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
FDA Enforcement
Class II
·Terminated·Med-Mizer, Inc.·May 14, 2014
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
FDA Enforcement
Class II
·Terminated·Nanosphere, Inc.·August 20, 2014
Product is a 15x16x27" (WxDxH) air purifier device with one of two different brands next to the control panel: HealthWay or CleanStation. HealthWay brand is sold under model number Deluxe 20600-3 Air Purification System. The CleanStation brand is sold under model number CS20000. The devices are intended to remove particles from the air for medical purposes
FDA Recall
Terminated
·Healthway Home Products, Inc.·Product code FRF·January 9, 2012
Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601
FDA Recall
Terminated
·Medibo N.V. Heikant 5 Hanmont, Achel Belgium·Product code FSA·August 4, 2004