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U.S. Department of Health and Human Services

Medical Device Recalls

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11 to 20 of 500 Results *
Date Classified to: 07/04/2014 510(K) Number: K101558
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Product Description
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Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the s... 2 Dec-16-2014 Philips Medical Systems, Inc.
Ascension Orthopedics PyroSphere CMC & PyroSphere TMT, intended to replace the joint between the fir... 2 Dec-16-2014 Integra LifeSciences Corp.
Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps are affected. Model: ... 2 Dec-16-2014 Philips Ultrasound, Inc.
EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or... 2 Dec-16-2014 Philips Ultrasound, Inc.
QLAB Quantification Software. QLAB version 10.0, 10.1 and 10.1.1 with a2DQ and/or aCMQ plug-ins are... 2 Dec-16-2014 Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or... 2 Dec-16-2014 Philips Ultrasound, Inc.
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the te... 2 Dec-16-2014 Biomet Microfixation, LLC
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the te... 2 Dec-16-2014 Biomet Microfixation, LLC
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temp... 2 Dec-16-2014 Biomet Microfixation, LLC
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the ... 2 Dec-16-2014 Biomet Microfixation, LLC

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