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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 500 Results *
Date Classified to: 02/01/2015 510(K) Number: K101558
 
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DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 3010... 2 Jan-30-2015 Express Diagnostics Int'l., Inc.
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion... 2 Jan-30-2015 Animas Corporation
HomeChoice/HomeChoice Pro Automated Personal Cycler 2 Jan-29-2015 Baxter Healthcare Corp.
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA... 3 Jan-29-2015 Arrow International Inc
Verasense Knee System, Model SYK-TRCR 02 2 Jan-29-2015 Orthosensor, Inc.
Portex® Anaerobic Pulsator® Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and El... 3 Jan-29-2015 Smiths Medical ASD, Inc.
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single... 2 Jan-29-2015 Fresenius Kabi USA, LLC
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for be... 2 Jan-28-2015 Synthes, Inc.
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical ... 2 Jan-28-2015 INNOKAS MEDICAL OY
Syngo.plaza: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display,... 2 Jan-28-2015 Siemens Medical Solutions USA, Inc

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