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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
 

 
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126 records meeting your search criteria returned- Product Code: DQA Product Problem: Incorrect, Inadequate or Imprecise Result or Readings Report Date From: 01/1/2007
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ManufacturerBrand NameDate Report Received
MASIMO - 15750 ALTON PKWY RAD-5 PULSE OXIMETER 08/16/2023
MASIMO CORPORATION RD SET 06/09/2023
MEDLINE INDUSTRIES, LP- NORTHFIELD PULSE OXIMETER 05/15/2023
MASIMO CORPORATION RD SET OXIMETER ADHESIVE SENSOR- ADULT 04/26/2023
MASIMO - 15750 ALTON PKWY RD SET NEOPT-500 04/07/2023
MASIMO CORPORATION RD SET 02/01/2023
MASIMO - 15750 ALTON PKWY GE CARESCAPE SP02 - MASIMO RAINBOW SET P 12/12/2022
MASIMO - 15750 ALTON PKWY RAD-8, HORIZONTAL 11/10/2022
ST PAUL BCI 3301 PULSE OXIMETER 11/01/2022
MASIMO CORPORATION RD SET NEONATE 10/26/2022
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