Carestream Health Inc. - DRX Revolution Mobile Xray System - Class 2 Recall
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on...
View ArticleBeckman Coulter Inc. - Coulter LH 750 Hematology Analyzer Coulter LH 780...
COULTER¿ LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical...
View ArticleStryker Instruments Div. of Stryker Corporation - Dekompressor Percutaneous...
Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral...
View ArticleEKOS Corporation - EKOS EkoSonic Control Unit - Class 2 Recall
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the...
View ArticleEdwards Lifesciences, LLC - Duraflo coated FemFlex Arterial Cannula - Class 2...
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended...
View ArticleEdwards Lifesciences, LLC - Edwards Duraflo coated Dispersion Tip Arterial...
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending...
View ArticleSmith & Nephew Inc - GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 5, LEFT -...
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
View ArticleSmith & Nephew Inc - GENESIS(R) II, NONPOROUS TIBIAL BASE, SIZE 6, RIGHT...
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
View ArticleSiemens Medical Solutions USA, Inc - Siemens RAD Fluoro Uro Systems - Class 2...
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems
View ArticleBayer Healthcare Llc - Bayer brand A1CNow MULTITEST A1C SYSTEM TEST KITS -...
Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC,...
View ArticleInsight Instruments, Inc. - MLS Torpedo MiniLight Ophthalmic singleport...
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
View ArticleSorin Group Deutschland GmbH - Sorin S5 Perfusionn System - Class 2 Recall
S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less.
View ArticleBeckman Coulter Inc. - UniCel DxH 800 and DxH 600 Coulter Cellular Analysis...
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in...
View ArticleRichard Wolf Medical Instruments Corp. - BiPolar Vaporization Electrodes -...
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111;...
View ArticleElekta, Inc. - Stereotactic Circular Collimator 3D Line stereotatic Hardware...
Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors.
View ArticleIntuitive Surgical, Inc. - Patient Cart used in conjunction with the da Vinci...
Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci...
View ArticleInvacare Corporation - Aquatec Ocean VIP - Class 2 Recall
Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function
View ArticleFresenius Medical Care Holdings, Inc. - Class 2 Recall
Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
View ArticleRoche Diagnostics Operations, Inc. - COBAS INTEGRA 800 Analyzer - Class 2 Recall
COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling...
View ArticleEthicon Endo-Surgery Inc - REALIZE - Class 2 Recall
Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical...
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