510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Keeler Ltd.

WINDSOR, BERKSHIRE Windsor and Maidenhead, GB

KEELER LTD. appears in FDA device records in WINDSOR, BERKSHIRE Windsor and Maidenhead, GB. FDA records list 9 510(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
9
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 9 510(k) clearances for Keeler Ltd. between 2010 and 2015. The busiest year on record is 2014, with 4. The most recent is 2015, with 2.

Clearances by year, as a table
510(k) clearance decisions for Keeler Ltd., by decision year
YearClearances
20101
20132
20144
20152
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K152644KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100HKYSubstantially Equivalent
K151394Keeler Slit LampHJOSubstantially Equivalent
K142179D-KAT Z-YPEHKYSubstantially Equivalent
K140451KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)HJOSubstantially Equivalent
K140450KEELER KAPTURE SOFTWAREHKISubstantially Equivalent
K133234T-TYPE D-KAT, R-TYPE D-KATHKYSubstantially Equivalent
K131787CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBESHRNSubstantially Equivalent
K131589KEELER SLIT LAMP H-SERIESHJOSubstantially Equivalent
K093445KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT)HKYSubstantially Equivalent

Registered establishments

FDA registered establishments for Keeler Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10003910041000391004KEELER LTD.CLEWER HILL RD., WINDSOR, BERKSHIRE Windsor and Maidenhead SL4 4AA GB2026and 11 more, listed in full below

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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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