65 results
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22ms
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Sources: EU EUDAMED, US FDA
HANAULUX 2004 IXL cupola, P/N: 56076868 Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible illumination for the surgical field or for the examination of the patient.
FDA Recall
Terminated
·MAQUET Inc.·Product code FTD·October 7, 2009
Diagnost 56/66/76/76 Plus, DSI is a Spot-Film and has a Digital Imaging Spot. Intended use is for the following applications: as a multifunctional/universal system, general R/F, Fluoroscopy, Radiology, and Angiography can be performed along with pediatric examinations and more specialized interventional applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXL·January 4, 2008
Philips BV Endura, Rel. 2, 718074. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010
Philips BV Pulsera, Rel. 2.3, 718095. Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
FDA Recall
Terminated
·Philips Medical Systems North America Co. Phillips·Product code IXL·December 14, 2010
VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·June 2, 2011
AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONREINF SURG GOWN 2XL XLONG, Item Code 9575EL
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
FDA Recall
Terminated
·Cardinal Health·Product code FYA·January 11, 2020
VITEK 2 XL computer system when equipped with the following Hewlett-Packard PC models: (1) rp5700, Cat. #W0452; (2) rp5700 (refurbished), Cat. #W0452R; (3) rp5800 XPE, Cat. 413642; (4) rp5800 WES7, Cat. #413862; (5) dc7100 8-port, Cat. #W0441; (6) dc7100 8-port (refurbished), Cat. #W0441R; (7) dc7700 8-port, Cat. #W0447; (8) dc7700 8-port (refurbished), Cat. #W0447R; (9) dc7800, Cat. #W0449; and (10) dc7800 (refurbished), Cat. #W0449R. VITEK 2 is an automated system designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.
FDA Recall
Terminated
·Biomerieux Inc·Product code LTW·February 18, 2013
Synthes CMF Battery Powered Driver, Part no. 305.840. Used to place screws in the cranialfacial bones, and to drill and/or tap holes to prepare cranialfacial bones for screw insertion.
FDA Recall
Terminated
·Synthes, Inc.·Product code GXL·January 30, 2014
Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.
FDA Recall
Terminated
·Medtronic Neurosurgery·Product code GXL·March 8, 2006
Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
FDA Recall
Terminated
·Biomet, Inc.·Product code PHX·April 17, 2020
Vial2BAG Transfer Device, REF 6070104, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Vial2BAG DC 20mm: 1) REF 6070112 & 2) REF 6070112C, Single use only, Rx Only
FDA Recall
Terminated
·WEST PHARMA. SERVICES IL, LTD 4, Ha-Sheizaf Ra'Anana Israel·Product code LHI·December 26, 2018
Toothete Oral Care Sodium Bicarbonate Mouthpaste, Net Wt. 1/3 oz/ 9g, included in Independent Care System. The system is an oral care convenience kit which includes: an Ultra-Soft Toothbrush, 0.5 oz. tube of Mouth Moisturizer, 0.33 oz. /9g tube of Sodium Bicarbonate Mouthpaste and 1.5fl.oz. bottle of Corinz oral rinse. Product Usage: The mouthpaste is used to clean teeth, gums, and the tongue.
FDA Recall
Terminated
·Sage Products Inc
3909 3 Oaks Rd
Cary IL 60013-1804·Product code NSB·December 5, 2018