Medical Device Manufacturer · US , Lincolnshire , IL

Midmark - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2009

Recent clearances: ELEVANCE, PROGENY VANTAGE PANORAMIC X-RAY SYSTEM

2
Total
2
Cleared
0
Denied

Midmark, is a medical device manufacturer specializing in dental and diagnostic imaging equipment. The company operates with a manufacturing facility in Lincolnshire, US, and serves medical, dental, and veterinary markets globally.

Midmark received 2 FDA 510(k) clearances from 2 total submissions. The company's cleared devices span dental imaging and radiology categories, with clearances granted between 2009 and 2012. This represents a historical regulatory record; no new clearances have been submitted in over a decade.

Notable cleared devices include the ELEVANCE dental system and the PROGENY VANTAGE PANORAMIC X-RAY SYSTEM for radiology applications. These products reflect the company's focus on intraoral imaging and diagnostic imaging solutions for clinical settings.

For detailed information on device names, product codes, and specific clearance dates, consult the FDA 510(k) database or contact the company directly.

510(k) submissions have been managed by Regulatory Technology Services, LLC as regulatory consultant.

FDA 510(k) Regulatory Record - Midmark

2 devices
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