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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Syngo.plaza, Picture Archiving and Communication System
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2
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09/27/2016
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Siemens Medical Solutions USA, Inc
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Syngo.plaza VB10A, Picture Archiving and Communication System
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2
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09/27/2016
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Siemens Medical Solutions USA, Inc
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Syngo RT Therapist, Accelerator, Linear, Medical
Syngo RT Therapist is a software application whose...
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2
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09/23/2016
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Siemens Medical Solutions USA, Inc
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McKesson Radiology, versions 12.1.1 and 12.2
McKesson Radiology (MR) is a Picture Archiving Co...
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2
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09/22/2016
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Mckesson Medical Imaging Group
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Merge Cardio software.
Product Usage:
Merge Cardio is an integrated cardiovascular information...
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2
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09/21/2016
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Merge Healthcare, Inc.
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Syngo.via picture archiving and communication system
Syngo via is a software solution intended to...
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2
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09/21/2016
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Siemens Medical Solutions USA, Inc
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Syngo.x picture archiving and communication system
Syngo.x is a software solution intended to be ...
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2
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09/21/2016
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Siemens Medical Solutions USA, Inc
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T2Candida®Cartridges; Part Number: 90-01794 (box of 12) and Part Number: 91-01534 (individual cartri...
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2
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09/14/2016
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T2 Biosystems Inc
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Syngo Plaza picture archiving and communication system (PAC) (PACS) intended to display, process, re...
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2
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09/14/2016
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Siemens Medical Solutions USA, Inc
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CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versio...
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2
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09/09/2016
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Biosense Webster, Inc.
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Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion...
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2
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09/08/2016
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Sorin Group USA, Inc.
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Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical ...
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2
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09/06/2016
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Ge Healthcare It
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Centricity Laboratory Core Lab System 4.1
The Centricity Laboratory System is intended to be an i...
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2
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08/26/2016
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GE Healthcare It
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NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and...
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2
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08/25/2016
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Novarad Corporation
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Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-32...
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1
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08/25/2016
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Cook Inc.
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GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communicati...
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2
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08/17/2016
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GE Healthcare It
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Zimmer® Air Dermatome II Handpiece, item number 00-8851-001-00.
The Zimmer Air Dermatome II hand...
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2
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08/04/2016
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Zimmer Surgical Inc
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Zimmer® Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside o...
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2
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08/04/2016
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Zimmer Surgical Inc
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Zimmer® Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01.
The Zimmer Air Dermatome...
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2
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08/04/2016
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Zimmer Surgical Inc
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Zimmer® Air Dermatome II Width Plate, 1 in., item number 00-8851-201-00 .
Width plates is package...
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2
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08/04/2016
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Zimmer Surgical Inc
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Zimmer® Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a ...
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2
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08/04/2016
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Zimmer Surgical Inc
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Zimmer® Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00.
Width plate is packaged in...
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2
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08/04/2016
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Zimmer Surgical Inc
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Zimmer® Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside o...
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2
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08/04/2016
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Zimmer Surgical Inc
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SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephe...
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2
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07/28/2016
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Smith & Nephew, Inc.
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Syngo.via, picture archiving and communications system software controlled.
Intended to be used f...
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2
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07/20/2016
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Siemens Medical Solutions USA, Inc
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HX2" Temperature Management Systems;
The Terumo® HX2" Temperature Management System provides tem...
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2
|
07/14/2016
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Terumo Cardiovascular Systems Corporation
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NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. P...
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2
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07/11/2016
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Novarad Corporation
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Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17.
Pro...
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2
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07/05/2016
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Exactech, Inc.
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Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18.
Fem...
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2
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07/05/2016
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Exactech, Inc.
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Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, ...
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2
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06/29/2016
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Siemens Medical Solutions USA, Inc
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LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365
The LEGION Hinge...
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2
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06/29/2016
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Smith & Nephew, Inc.
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LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364
The LEGION Hin...
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2
|
06/29/2016
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Smith & Nephew, Inc.
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LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374
The LEGION Hing...
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2
|
06/29/2016
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Smith & Nephew, Inc.
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LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363
The LEGION Hin...
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2
|
06/29/2016
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Smith & Nephew, Inc.
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LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373
The LEGION Hing...
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2
|
06/29/2016
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Smith & Nephew, Inc.
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LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375
The LEGION Hinge ...
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2
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06/29/2016
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Smith & Nephew, Inc.
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Fujifilm Synapse PACS software version 4.4.000,
Fujifilm Synapse PACS software version 4.4.001,
Fu...
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2
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06/21/2016
|
Fujifilm Medical Systems U.S.A., Inc.
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Lipase, Catalog No. OSR6x30
Product Usage:
Lipase OSR6x30 is intended as a System reagent for th...
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2
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06/08/2016
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Beckman Coulter Inc.
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Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic ...
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2
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06/07/2016
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Remel Inc
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Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouch...
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2
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06/07/2016
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Medical Components, Inc dba MedComp
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The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospit...
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2
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06/03/2016
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Hospira Inc.
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The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such ...
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2
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06/03/2016
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Hospira Inc.
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Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparosc...
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2
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05/06/2016
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Applied Medical Resources Corp
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Syngo Dynamics; Kinetdx Picture Archiving and Communications System
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2
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05/04/2016
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Siemens Medical Solutions USA, Inc
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Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A
The Dialog+ can be used for ...
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1
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05/03/2016
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B Braun Medical Inc
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Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A
The Dialog+ can be used fo...
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1
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05/03/2016
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B Braun Medical Inc
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Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algo...
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2
|
05/03/2016
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Nuvectra
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enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 1...
|
2
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04/26/2016
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Ortho-Clinical Diagnostics
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The Concerto Basic Shower Trolley is intended for assisted hygiene care, especially showering and ba...
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2
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04/14/2016
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Arjo, Inc. dba ArjoHuntleigh
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A Picture Archiving and Communication System (PACS) intended to display, process, read, report, comm...
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2
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04/07/2016
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Siemens Medical Solutions USA, Inc
|