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HAWK

DXM CO., LTD · Model HD · UDI-DI 08800017900025

EIA Prescription

510(k) clearances

1,409

Adverse events

Recalls

111

Facilities

Description

Highest resolution 1280 x 720 delivers precise, true-to-life images auto-focus system 15 advanced LED lights for the correct color representation

Recalls

Date	Firm	Reason
2016-06-24	Danville Materials, Inc.	The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data
2014-04-23	William C. Domb, D.M.D., A Professional Corporation	William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or cleared by the FDA for medical use.
2013-11-05	ASI Medical, Inc.	ASI Medical is initiating a field correction for the SEAC Advanced Dental System because the miniature plastic air tank can potentially rupture.
2012-02-20	Pelton & Crane Company	Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.