32 results
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Siemens Dimension RxL and Xpand assays. The wash buffer is used to clean the probe sensor between uses and prepares it for taking the next reading/measurement.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·August 27, 2014
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc.·January 1, 2014
INVUITY(R) PhotonBlade(TM), REF PB1
FDA Enforcement
Class II
·Terminated·Invuity, Inc.·August 2, 2017
Malaria pan Antigen Test; LumiQuick, Santa Clara, CA 95054
FDA Enforcement
Class II
·Terminated·LumiQuick Diagnostics Inc.·April 16, 2014
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
FDA Recall
Terminated
·Salyer Prn Biomedical·Product code DTQ·January 31, 2013
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Recall
Terminated
·Derma Pen, LLC·Product code PIU·February 5, 2015
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
FDA Enforcement
Class II
·Terminated·Galt Medical Corporation·August 8, 2018
Malaria pf/pan Antigen Test Card; LumiQuick. Santa Clara, CA 95054
FDA Enforcement
Class II
·Terminated·LumiQuick Diagnostics Inc.·April 16, 2014
DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
FDA Enforcement
Class II
·Terminated·Derma Pen, LLC·September 16, 2015
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
FDA Enforcement
Class II
·Terminated·Salyer Prn Biomedical·March 13, 2013
ANTI-PAN Keratin Primary Antibody, 25 mL, Catalog Number 05266840001, model 760-2135 Immunohistochemistry (IHC) for in vitro diagnostic use.
FDA Enforcement
Class I
·Terminated·Ventana Medical Systems Inc·September 26, 2018
Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
FDA Recall
Terminated
·Galt Medical Corporation·Product code DYB·May 2, 2018
Fluorocell PLT reagent, Catalog #CD994563 Fluorocell PLT is used to stain platelets in a diluted blood sample for the counting of platelets with the Sysmex XN-Series automated hematology analyzers
FDA Enforcement
Class II
·Terminated·Sysmex America Inc·September 21, 2016
smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indicated for patients who would benefit from a suction device particularly as the device may promote healing when used with accessory wound sealing kits. Made in USA by/Fabrique aux Etals Unis par: Smith & Nephew, Inc., Largo, FL 33773 Smith & Nephew Medical Limited Hull HU3 2BN England
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code OMP·January 29, 2010
***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE***Rx Only.***Made in Mexico for/Fabrique au Mexique pour: Smith & Nephew, Inc., St. Petersburg, FL 33716***Smith & Nephew Medical Limited Hull HU3 2BN England***Lot 123456. Product Usage: The product is a suction device used as an accessory to the foam dressing kits, which is used in conjunction with Smith & Nephew Negative Pressure Wound Therapy (NPWT) systems to deliver negative pressure to a wound.
FDA Recall
Terminated
·Smith & Nephew Inc.·Product code OMP·December 14, 2010
LIGHT DIAGNOSTICS SimulFluor Flu A/Flu B DFA Kit Immunofluorescence Assay Cat. No. 3121 FOR IN VITRO DIAGNOSTIC USE Authorized Representative: Millipore (UK) Ltd. Fleming Road, Kirkton Campus Livingston EH54 7BN UK. Tel +44 1506 404000 Fax +44 1506 404073 MILLIPORE 28820 Single Oak Drive Temecula, CA 92590 " USA & Canada Phone: +1(800) 437-7500 " Fax: +1 (951) 676-9209. The kit consists of Catalog #5250 Simulfluor Flu A/B; Catalog #5010 Flu A/B Control Slide; Catalog #5013 Mounting Fluid; Catalog #5037 Tween 20/Sodium Azide, 100X; Catalog #5087 PBS Packet
FDA Recall
Terminated
·Millipore Corporation·Product code GNW·November 24, 2008
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System, used with a Model 7100 Ventillator, on a Aestiva/5 Anesthesia Machine.
FDA Recall
Terminated
·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004
Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code FBN·March 31, 2022
Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used with a Model 7900 Ventillator, on a Aestiva/5 Anesthesia Machine
FDA Recall
Terminated
·Datex-Ohmeda Inc One Ohmeda·Product code CBN·April 16, 2004
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
FDA Recall
Terminated
·Boston Scientific Corporation·Product code FBN·December 20, 2017