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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
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

 
 
5 records meeting your search criteria returned- Product Code: BZD Product Problem: Inadequate Instructions for Non-Healthcare Professional Report Date From: 01/1/2019
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ManufacturerBrand NameDate Report Received
RESMED PTY LTD AIRFIT N30 CUSHION MEDIUM 06/12/2023
RESMED PTY LTD AIRFIT N30 MASK SYSTEM M - AMER 06/12/2023
PHILIPS/RESPIRONICS, INC. PHILIPS DREAMSTATION CPAP 11/23/2022
PHILIPS/RESPIRONICS, INC. PHILIPS DREAMSTATION BIPAP 11/23/2022
PHILIPS/ RESPIRONICS, INC. CPAP DREAMSTATION 08/03/2021
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