52 results
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21ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.
FDA Enforcement
Class II
·Terminated·SCC Soft Computer·August 15, 2012
Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Medtronic CardioVascular·Product code FGE·July 17, 2009
Complete SE Biliary Stent System, SC5120L (5 mm x 12 mm), lot number 0000983799, UPC code 00613994186478, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. Indicated for use in the palliation of malignant neoplasms in the biliary tree.
FDA Recall
Terminated
·Medtronic CardioVascular·Product code FGE·July 17, 2009
PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014
Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH. Product Usage: The Compression guide is a re-usable instrument used in the implantation of the Tibiaxys product. The Tibiaxys system is intended for fixation of bone fractures or for bone reconstruction (arthrodesis, osteotomies, and fractures of ankle joint, distal tibia and fibula).
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code OYK·November 17, 2011
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·September 19, 2011
Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085, in vitro diagnostic
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JIT·November 17, 2011
Cannula 8MM Regular. Provides the means of introduction and placement of an instrument or accessory into the human body.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·September 19, 2011
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
FDA Recall
Terminated
·Intuitive Surgical, Inc.·Product code NAY·September 19, 2011
Pulmonary Hemi-Artery SG Used in heart surgery
FDA Recall
Terminated
·CryoLife, Inc.·Product code DXZ·February 17, 2011
Pulmonary Valve & Conduit SG Used in heart surgery
FDA Recall
Terminated
·CryoLife, Inc.·Product code DXZ·February 17, 2011
Varian Medical Systems Inc., Millennium and HD-120 MultiLeaf Collimators (MLC), a component of the Clinac, All Varian Clinac using the collimator cover P/N 1106900-xx, Model Numbers: H14, H18, H27, H29, HCX; part of the Trilogy Radiotherapy Delivery System.
FDA Recall
Terminated
·Varian Medical Systems, Inc.·Product code IYE·March 17, 2011
BD 30G1/2" Precision Glide" Needle Needles are used for aspiration and injection of medications
FDA Recall
Terminated
·Becton Dickinson & Company·Product code FMI·October 8, 2011
Arrow ASK-20608-CMC StimuCath Continuous Nerve Block Kit. Arrow International, Inc. Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
FDA Recall
Terminated
·Arrow International Inc·Product code CAZ·June 17, 2011
GE Healthcare Carescape Patient Data Module with v2.0 software used with Solar 8000M/l, Transport Pro or Carescape B650/B850 host monitor. The Patient Data Module (PDM) is intended to provide physiologic parameter data on adult, pediatric and neonatal patients during bedside and transport patient care episodes.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MHX·February 17, 2012
GE SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM ( SENO 2000D). The Senographe 2000D system generates digital mammographic images that can be used for screening and in the diagnosis of breast cancer. The Senographe 2000D is intended to be used in the same clinical applications as traditional mammographic film/screen systems.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code MUE·October 17, 2011
LPCCC2: Low Profile Abutment Non-Hexed Castable Cylinder by Biomet 3i Castable cylinders are intended to be used to produce a definitive casting for dental restoration onto which porcelain can then be cast
FDA Recall
Terminated
·Biomet 3i, LLC·Product code NHA·March 14, 2011
STERIS 5085 and 5085SRT Surgical Tables, Catalog Numbers: 5085- ST01-410-1; 5085SRT- ST0-1420-6.
FDA Recall
Terminated
·Steris Corporation·Product code FQO·October 17, 2011
Maquet HL Console for Heart Lung Machine HL20: HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 The HL 20 is indicated for use as an extracorporeal circulation device for perfusion lasting not more then six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
FDA Recall
Terminated
·Maquet Inc.·Product code DTQ·June 20, 2011
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas.
FDA Recall
Terminated
·Kerr Corporation·Product code EBA·November 17, 2011