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U.S. Department of Health and Human Services

MAUDE - Manufacturer and User Facility Device Experience

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Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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17 records meeting your search criteria returned- Product Code: OMP Product Problem: Noise, Audible Report Date From: 01/1/2017
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ManufacturerBrand NameDate Report Received
SMITH & NEPHEW MEDICAL LTD. UNKN PICO 7 11/24/2021
SMITH & NEPHEW MEDICAL LTD. RENASYS GO 07/02/2021
KINETIC CONCEPTS, INC. ACTIV.A.C. ION PROGRESS REMOTE THERAPY M 06/03/2021
SMITH & NEPHEW MEDICAL LTD. RENASYS GO 04/27/2021
SMITH & NEPHEW MEDICAL LTD. PICO 7 15CM X 15CM 04/20/2021
SMITH & NEPHEW MEDICAL LTD. RENASYS EZ MAX, HOSPITAL 04/08/2021
SMITH & NEPHEW MEDICAL LTD. PICO 7 SINGLE DRSG 15CM X 20CM 04/06/2021
SMITH & NEPHEW MEDICAL LTD. RENASYS GO 03/28/2021
SMITH & NEPHEW MEDICAL LTD. RENASYS GO 03/03/2021
SMITH & NEPHEW MEDICAL LTD. PICO WITH SOFT PORT 15X15CM 02/14/2021
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