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Midmark
MIDMARK CORPORATION · Model ADS-1100-001 · UDI-DI 00841709121876
EIA
Prescription
1
510(k) clearances
1,410
Adverse events
4
Recalls
112
Facilities
Description
Midmark Assistant's Delivery Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes and accessories during dental examinations and procedures
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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Get your free API keyRead the docsData 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.