510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Carl Zeiss Meditec Cataract Technology Inc

Reno, NV, US

Carl Zeiss Meditec Cataract Technology Inc appears in FDA device records in Reno, NV. FDA records list 7 510(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
7
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 7 510(k) clearances for Carl Zeiss Meditec Cataract Technology Inc between 2019 and 2025. The busiest year on record is 2020, with 2. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Carl Zeiss Meditec Cataract Technology Inc, by decision year
YearClearances
20191
20202
20222
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243395MICOR 700 with Auto I/AHQCSubstantially Equivalent
K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)HQCSubstantially Equivalent
K214028MICOR Lens Fragmentation SystemHQCSubstantially Equivalent
K222236miCOR System Lens Fragmentation SystemHQCSubstantially Equivalent
K200207xPORT S Lens Fragmentation SystemHQCSubstantially Equivalent
K200584xPORT 304 (miCOR) System Lens Fragmentation SystemHQCSubstantially Equivalent
K191024xPORT Lens Fragmentation SystemHQCSubstantially Equivalent

Registered establishments

FDA registered establishments for Carl Zeiss Meditec Cataract Technology Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30121230333012123033Carl Zeiss Meditec Cataract Technology Inc8740 Technology Way, Reno, NV 89521 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