186 results
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14ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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CINtec PLUS Cytology Kit (CE-IVD), Ventana Part Number 605-100, Roche GMMI 06889565001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code HYJ·December 19, 2017
CINtec PLUS Cytology Kit (Canada/Japan), Ventana Part Number 805-100, Roche GMMI 06889549001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ultraView SISH DNP Detection Kit US, Ventana Part Number 760-098, Roche GMMI 05572037001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code PPM·December 19, 2017
iView DAB IHC Detection Kit, Ventana part Number 760-091, Roche GMMI 05266157001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
OptiView Amplification Kit, Ventana Part Number 760-099, Roche GMMI 06396518001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ultraView SISH Detection Kit, Ventana Part Number 780-001, Roche GMMI 05271967001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code PPM·December 19, 2017
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Ventana Part Number 760-041, Roche GMMI 05266084001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ultraView Universal DAB Detection Kit, Ventana part Number 760-500, Roche GMMI 05269806001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
OptiView Amplification Kit (250 Test), Ventana Part Number 860-099, Roche GMMI 06718663001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
ultraView SISH DNP Detection Kit, Ventana Part Number 800-098, Roche GMMI 05907136001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code PPM·December 19, 2017
OptiView DAB IHC Detection Kit, Ventana Part Number 760-700, Roche GMMI 06396500001 in vitro diagnostic
FDA Recall
Terminated
·Ventana Medical Systems Inc·Product code NJT·December 19, 2017
Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020
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
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