Notice of the Class I Recall of the Olympic Cool-Cap System
The FDA notified health care professionals of a Class I Recall of the Olympic cool-cap system from Natus Medical Inc.
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FDA Announces Plan to Speed Access to New Device Technologies
Dec 7, 2012 | Government Regulations, Recalls | 0 |
The FDA announces that it is part of the first public-private partnership to promote medical device regulatory science with a focus on speeding the development, assessment, and review of new medical devices.
Read MoreSpacelabs Monitor Recall Continues
In the FDA Enforcement Report for the week of November 28, it lists the ongoing recall of the Qube compact monitor (patient monitor) 91390.
Read MoreThe FDA Class I Recall of the HeartSine Samaritan Public Access Defibrillator
Initiated September 13, 2012, the Class I Recall involves the HeartSine Samaritan 300/300P public access defibrillator (PAD), manufactured and distributed from August 1, 2004 to January 31, 2011.
Read MoreMindray DS USA Continues its Anesthesia Delivery System Recall
Mindray Medical International Ltd, a developer, manufacturer, and marketer of medical devices worldwide, continues its August 8, 2012 voluntary recall affecting the A3/A5 anesthesia delivery system.
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