116 results
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29ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Corporation·June 14, 2017
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code KDJ·April 28, 2014
The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials.
FDA Enforcement
Class II
·Terminated·Kerr Corporation·November 14, 2012
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. Hip prosthesis component. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·May 27, 2015
Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.
FDA Enforcement
Class II
·Terminated·Instrumed International, Inc.·October 8, 2014
Continu-Flo Solution Set, 10 drops/mL, 104'', 0.22 Micron Downstream High Pressure Extended Life Filter, 3 Injection Sites, Male Luer Lock Adapter, catalog 2C6593; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
FDA Recall
Terminated
·Baxter Healthcare Corp. Rt·Product code FPA·July 16, 2003
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland) Limited, County Offaly, Ireland; Distributed by Integra Life Sciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·July 29, 2010
Atlantis PV Peripheral Imaging Catheter, model number H749364560, catalog number 36456, manufactured by Boston Scientific Corporation, Fremont, CA. Medical device, intended for ultrasound examination of peripheral pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
FDA Recall
Terminated
·Boston Scientific Corporation·Product code ITX·October 9, 2008
Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32441
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 22, 2020
Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32443
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 22, 2020
Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens Catalog Number: A32444
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 22, 2020
Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated from non-small cell lung cancer (NSCLC) tumor specimens, Catalog Number: A32442.
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 22, 2020
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 25, 2018
HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer pair is specific for HSV-2 (Herpes Simplex Virus 2). For use in Clinical laboratories when developing their own diagnostic tests.
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·September 4, 2013
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·May 2, 2018
Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461; UDI: (01)10190302006071(11)170911(10)1.8(240)A32461 The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that uses targeted high- throughput, parallel-sequencing technology to detect single-nucleotide variants (SNVs) and deletions in 23 genes from DNA and fusions in ROS1 from RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples from patients with non-small cell lung cancer (NSCLC) using the Ion PGM Dx System. The test is indicated to aid in selecting NSCLC patients for treatment with the targeted therapies listed in Table 1 in accordance with the approved therapeutic product labeling.
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·April 11, 2018
CTSTM Essential 8 Medium
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·November 13, 2019
StemPro¿ MSC SFM CTS"
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·November 13, 2019
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·September 23, 2020
The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretive Software v2.0 or v2.2 (used with the QuantStudio Real-Time PCR platforms), includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software
FDA Enforcement
Class II
·Terminated·Life Technologies Corporation·September 23, 2020