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Sources: EU EUDAMED, US FDA
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FDA Recall
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VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.
FDA Recall
Terminated
·Carl Zeiss Meditec, Inc.·Product code OTL·December 6, 2018
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is designed to enter the disc space, with a fixed engagement between the inserter and the cage and then rotate for desired placement. The three components of the TL Steerable Inserter System include: 1. TL Steerable Inserter 2. TL Steerable Inserter Inner Shaft 3. TL Steerable Inserter Driver
FDA Recall
Terminated
·Howmedica Osteonics Corp.·Product code LXH·September 12, 2018
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H8mm, Part #018.1908.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050
FDA Recall
Terminated
·CTL Medical Corporation·Product code MNI·July 5, 2018
Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
CTL Medical Hex Driver MIS, 1/4" Square QC, 4.0 Ratcheting Ref 019.7050
FDA Recall
Terminated
·CTL Medical Corporation·Product code NKB·July 5, 2018
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H7mm, Part #018.1307.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L26, H8mm, Part #018.1308.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
FDA Recall
Open, Classified
·Oto Med Inc·Product code MXP·December 7, 2020
CEZANNE II TLIF Bullet-Tip Cage, 8Deg, W11 x L30, H7mm, Part #018.1907.
FDA Recall
Completed
·CTL Medical Corporation·Product code MAX·August 21, 2019
Esaote brand Formul@ ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand ArchiWin Colour ECG System; part 9704325000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Archimed 4220 ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Esaote brand Formula for Archimed ECG System; part 9704220000.
FDA Recall
Terminated
·Esaote Biomedica S.P.A. c/o The Anson Group·Product code DPS·December 23, 2003
Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
FDA Recall
Terminated
·Vascular Solutions, Inc.·Product code DTL·February 27, 2013
ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242
FDA Recall
Terminated
·Abbott Vascular-Cardiac Therapies dba Guidant Corporation·Product code DTL·December 5, 2006
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614.
FDA Recall
Terminated
·Edwards Lifesciences Llc·Product code DTL·October 19, 2010
GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code BTL·June 26, 2012
MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically powered transport emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require ventilation.
FDA Recall
Terminated
·Thornhill Research Inc·Product code BTL·November 19, 2015