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510(k) Premarket Notification - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081136
- INSOUND MEDICAL INC. 39660 EUREKA DRIVE: NEWARK, CA 94560 Applicant Contact: SUSAN WHICHARD: Correspondent: INSOUND MEDICAL INC. 39660 EUREKA DRIVE ... Recalls: CDRH Recalls - - Links on this page: Page Last Updated: 12/05/2022.
Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
- Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could …
Class 2 Device Recall Lyric Hearing Aid - Food and Drug …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=88543
- Recall Status 1: Terminated 3 on August 02, 2011: Recall Number: Z-1681-2010: Recall Event ID: 54473: 510(K)Number: K081136 Product Classification: hearing …
International Medical Devices Database
- https://medicaldevices.icij.org/manufacturers/u-s-food-and-drug-administration-insound-medical-inc-insound-medical-inc-37500-central-ct-newark-ca-94560-3454
- InSound Medical, Inc., 37500 Central Ct, Newark CA 94560-3454 Manufacturer Parent Company (2017) Sonova Holding Ag Source USFDA 1 Event Recall of Device Recall …
Medical Device Recalls
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=54473
- Related Medical Device Recalls: Results per Page New Search Export to Excel | Help. Product Description. Recall Class. FDA Recall Posting Date. Recalling Firm. Z-1681 …
International Medical Devices Database
- https://medicaldevices.icij.org/devices/usa-ear-nose-and-throat-devices-device-recall-lyric-hearing-aid
- Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. ... InSound Medical, Inc., 37500 …
Acquisition of InSound Medical Inc. | Sonova International
- https://www.sonova.com/en/acquisition-insound-medical-inc
- InSound Medical developed the first extended wear hearing system which is placed deep in the ear canal and totally invisible from the outside, and markets it under …
Sonova Acquires InSound Medical For $75 Million Plus …
- https://hearingreview.com/inside-hearing/people/sonova-acquires-insound-medical-for-75-million-plus-earn-out-payments
- Sonova Holding, AG, Stafa, Switzerland, has acquired InSound Medical Inc, Newark, Calif, developer of the Lyric extended wear hearing aid—for an up-front cash …
InSound(R) Medical Acquired by Sonova - PR Newswire
- https://www.prnewswire.com/news-releases/insoundr-medical-acquired-by-sonova-80781372.html
- NEWARK, Calif., Jan. 6 /PRNewswire/ -- InSound Medical, which created and markets Lyric, the world's first "100% invisible, extended wear" hearing aid, announced …
MAUDE Adverse Event Report: INSOUND MEDICAL …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2580998
- INSOUND MEDICAL LYRIC: Back to Search Results: Model Number 01-0079-163: Device Problem Adverse Event Without Identified Device or Use Problem (2993) ... Search …
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