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Medicatech USA

Anaheim, CA, US

MEDICATECH USA appears in FDA device records in Anaheim, CA. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
10
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 10 510(k) clearances for Medicatech USA between 2008 and 2025. The busiest year on record is 2011, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Medicatech USA, by decision year
YearClearances
20082
20113
20131
20151
20191
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242731MasteRad MiniX Mobile Digital Imaging System (Mini-X)OWBSubstantially Equivalent
K230918MasterX 800 SeriesMQBSubstantially Equivalent
K190601MasteRad MX30KPRSubstantially Equivalent
K143257KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic SystemKPRSubstantially Equivalent
K130377KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMMQBSubstantially Equivalent
K112132KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEMMQBSubstantially Equivalent
K102285KRYSTALRAD (ATAL8)KPRSubstantially Equivalent
K102284KRYSTALRAD 560 (FLAATZ 560)KPRSubstantially Equivalent
K082798DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000KPRSubstantially Equivalent
K080582MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FAKPRSubstantially Equivalent

Registered establishments

FDA registered establishments for Medicatech USA, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30049898043004989804MEDICATECH USA1245 N Patt St, Anaheim, CA 92801 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain