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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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152 records meeting your search criteria returned- Product Code: HWE Product Problem: Self-Activation or Keying Report Date From: 01/1/2016
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ManufacturerBrand NameDate Report Received
ARTHREX, INC. SYNERGY RESECTION SHAVER CONSOLE 03/12/2021
SMITH & NEPHEW, INC. MOT DR UNIT, HNDCONT POWERMAX ELITE 09/06/2018
SMITH & NEPHEW, INC. MOT DR UNIT, HNDCONT POWERMAX ELITE 09/06/2018
SMITH & NEPHEW, INC. MOT DR UNIT, HNDCONT POWERMAX ELITE 05/11/2018
DEPUY SYNTHES PRODUCTS LLC ELECTRIC PEN DRIVE 60,000 RPM 12/11/2017
SMITH & NEPHEW, INC. SVC REPL,MDU, HAND CNTRL, PWRMX 10/20/2017
SMITH & NEPHEW, INC. SVCE,MOT DR UNIT, HNDCONT POWERMAX ELITE 08/03/2017
DEPUY SYNTHES POWER TOOLS QC F/K-WIRES Ø0.6-3.2 F/532.001 532.010 06/05/2017
DEPUY SYNTHES POWER TOOLS EPD 60000 RPM 12/06/2016
DEPUY SYNTHES POWER TOOLS ELECTRIC PEN DRIVE 12/06/2016
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