12 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
FDA Enforcement
Class II
·Terminated·ARJOHUNTLEIGH POLSKA Sp. z.o.o.·August 26, 2020
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
FDA Recall
Terminated
·ARJOHUNTLEIGH POLSKA Sp. z.o.o. Ui. Ks. Piotra Wawrzyniaka 2 Komorniki Poland·Product code FNL·July 21, 2020
ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
FDA Enforcement
Class II
·Terminated·The Anspach Effort, Inc.·August 5, 2015
ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
FDA Recall
Terminated
·The Anspach Effort, Inc.·Product code HBE·April 13, 2015
Measles IgG ELISA 96 Well Kit, Catalog Number: MS018G The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LJB·August 27, 2008
Measles IgM ELISA 96 Well Kit, Catalog Number: MS019M The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only.
FDA Recall
Terminated
·Calbiotech Inc·Product code LJB·August 27, 2008
Navigator System Surgical kit (SGKIT), handles inside of SGKIT Surgical Kit SGDPH1 through SGDPH5. The product is used for CT guided surgery.
FDA Recall
Terminated
·Biomet 3i, Inc.·Product code EJB·May 9, 2008
Measles IgG Enzyme Immunoassay Test Kit, DIAMEDIX. The assay is intended for the semi-quantitation of human IgG antibodies to measles virus in human serum by indirect immunoassay to aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals and, when evaluating paired sera, as an aid in the diagnosis of measles infection.
FDA Recall
Terminated
·Diamedix Corporation·Product code LJB·October 10, 2008
Lenstar LS 900 EyeSuite Biometry version i2.000, Four (4) Protective Cardboard Containers Per Each System. Haag-Streit USA, Inc. A non-invasive, non-contact OLCR (Optical Low Coherence Reflectometer) Biometer used for obtaining ocular measurements and performing calculations to assist in determination of the appropriate power and type of IOL (Intraocular Lens) for implantation after removal of the natural crystalline lens following cataract removal.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code HJB·June 20, 2011
Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900, Distributed by: Haag-Streit USA, Inc., 3535 Kings Mills Rd., Mason, OH 45040 Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye.
FDA Recall
Terminated
·Haag-Streit USA Inc·Product code HJB·November 14, 2011
Measles (Rubeola) IgG ELISA Test System. It is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG antibodies to Measles (Rubeola) virus in human serum and is for in vitro diagnostic use. Product Number: 507055
FDA Recall
Terminated
·Zeus Scientific Inc·Product code LJB·March 19, 2001
KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A
FDA Recall
Terminated
·Kavo America Corporation·Product code EFB·November 22, 2006