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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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10 records meeting your search criteria returned- Product Code: HIH Product Problem: Leak/Splash Report Date From: 01/1/2009
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ManufacturerBrand NameDate Report Received
OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR 03/20/2024
HOLOGIC, INC. MYOSURE 05/04/2023
OLYMPUS WINTER & IBE GMBH RESECTION SHEATH, 8 MM, FOR 8.5 MM/26 FR 01/17/2023
SHIRAKAWA OLYMPUS CO., LTD. OES HYSTEROFIBERSCOPE 12/11/2022
HOLOGIC, INC. MYOSURE TISSUE REMOVAL DEVICE 10/22/2019
MITG-OKLAHOMA CITY UNKNOWN TRUCLEAR 09/25/2017
TRUCLEAR HANDPIECE TRUCLEAR HANDPIECE 06/08/2017
MITG - OKLAHOMA CITY TRUCLEAR 5.0 OP HYSTERSCOPE 06/08/2017
SMITH & NEPHEW INC., ENDOSCOPY DIVISION TRUECLEAR HYSTEROSCOPIC FLUID MANAGEMENT 07/19/2016
HOLOGIC LIMITED PARTNEP AQUILEX PUMP ASSY 02/27/2015
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