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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: 07/31/2014 510(K) Number: K070359
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Product Description
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Recalling Firm
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MC500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Fremont, CA: Manufactured by... 2 Jul-30-2014 Nidek Inc
Dimension® Integrated Chemistry Systems intended to measure a variety of analytes in human body flui... 3 Jul-30-2014 Siemens Healthcare Diagnostics, Inc.
Zimmer® Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation ... 2 Jul-30-2014 Zimmer, Inc.
The Patient Data Manager (Digital Lightbox) is a system intended for the display of medical images. ... 2 Jul-30-2014 Brainlab AG
Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and I... 2 Jul-30-2014 Small Bone Innovations
RUSCH, TruLite, One-Piece Disposable Laryngoscope Handle Blade Combination, Non-Sterile, Rx Only, Di... 2 Jul-29-2014 Teleflex Medical
Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL unit dose ... 2 Jul-29-2014 Novocol, Inc.
Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to adhere restor... 2 Jul-29-2014 Novocol, Inc.
FlowCOUPLER The FlowCOUPLER Device is a single use, implantable device that is intended to be use... 2 Jul-29-2014 Baxter Healthcare Corporation
DeRoyal (R) Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Rx Only STERILE EO, Distributed by... 2 Jul-29-2014 DeRoyal Industries Inc

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