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

Palo Alto, CA, US

Nidek, Inc. appears in FDA device records in Palo Alto, CA. FDA records list 32 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
32
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 32 510(k) clearances for Nidek, Inc. between 1984 and 1991. The busiest year on record is 1986, with 8. The most recent is 1991, with 4.

Clearances by year, as a table
510(k) clearance decisions for Nidek, Inc., by decision year
YearClearances
19842
19853
19868
19871
19886
19893
19905
19914
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K912384DISPOSABLE SUPPLIES KIT FOR PEA PROCEDUREHQESubstantially Equivalent
K913465NIDEK MODELS AC-2100 & 2200GEXSubstantially Equivalent
K913189NIDEK MODEL NT-1000HKXSubstantially Equivalent
K903639NIDEK DC-3000 DIODE LASER PHOTOCOAGULATORGEXSubstantially Equivalent
K903326NIDEK US-2000IYOSubstantially Equivalent
K902411NIDEK US-2500 W/BIOMETRY UNIT US-2520IYOSubstantially Equivalent
K902500AR-1600G AUTO-REFRACTOMETERHKOSubstantially Equivalent
K901686NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000HQCSubstantially Equivalent
K901513NIDEK RT-1200S (MARCO TRS-1200)HKOSubstantially Equivalent
K894709NIDEK MODEL ADC-8000GEXSubstantially Equivalent
K894273NIDEK MODEL AKC-8000HQFSubstantially Equivalent
K890559NIDEK AR-1200HKOSubstantially Equivalent
K884188NIDEK LM-870 AUTOMATIC LENSMETERHLMSubstantially Equivalent
K883213NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)HQFSubstantially Equivalent
K882162NIDEK US-3000IYOSubstantially Equivalent
K882191NIDEK ARK-2000HKOSubstantially Equivalent
K880929NIDEK CV-4000HQESubstantially Equivalent
K880065NIDEK UP-2000IYOSubstantially Equivalent
K872846NIDEK ADC-8000 LASER SYSTEMHQFSubstantially Equivalent
K862137NIDEK KM-1000 SURGICAL KERATOMETERHLQSubstantially Equivalent
K861064LM-850 AUTOMATIC LENSMETERHLMSubstantially Equivalent
K861065AR-1100 AUTOMATIC REFRACTORHKOSubstantially Equivalent
K854389NIDEK US-1600 A-SCANIYOSubstantially Equivalent
K861066AR-1000 AUTOMATIC REFRACTORHKOSubstantially Equivalent
K861063NIDEK KM-800 AUTO KERATOMETERHLQSubstantially Equivalent
K861062AR-1600 AUTOMATIC REFRACTORHKOSubstantially Equivalent
K860011NIDEK AC-2000 LASER SYSTEMHQBSubstantially Equivalent
K844971MONOCULAR DIRECT OPHTHALMOSCOPEHLISubstantially Equivalent
K843597NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPEHLISubstantially Equivalent
K843596NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPEHLISubstantially Equivalent
K844198ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODEHQBSubstantially Equivalent
K844197ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYSHQBSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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