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

Hatboro, PA, US

NIKOMED U.S.A., INC. appears in FDA device records in Hatboro, PA. FDA records list 15 510(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
15
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 15 510(k) clearances for Nikomed U.S.A., Inc. between 1987 and 2003. The busiest year on record is 1995, with 11. The most recent is 2003, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nikomed U.S.A., Inc., by decision year
YearClearances
19871
19901
199511
20001
20031
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K022909NIKOMED TRACE 1 ECG ELECTRODESDRXSubstantially Equivalent
K000079NIKOPAD ELECTROSURGICAL GROUNDING PAD, MODEL 4777MHAMSubstantially Equivalent
K950473DISPOSABLE ECG MONITORING ELECTRODEDRXSubstantially Equivalent
K950475DISPOSABLE ECG MONITORING ELECTRODE #4530, #4540DRXSubstantially Equivalent
K950472DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MMDRXSubstantially Equivalent
K950480DISPOSABLE ECG MONITORING ELECTRODE #4539 28X45MMDRXSubstantially Equivalent
K950478DISPOSABLE ECG MONITORING ELECTRODE #4570 38X60MMDRXSubstantially Equivalent
K950477DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MMDRXSubstantially Equivalent
K950474DISPOSABLE ECG MONITORING ELECTRODE #4533 32X45MMDRXSubstantially Equivalent
K950471DISPOSABLE ECG MONITORING ELECTRODE #4580 32X45MMDRXSubstantially Equivalent
K950470DISPOSABLE ECG MONITORING ELECTRODE #4535 32X45MMDRXSubstantially Equivalent
K950479DISPOSABLE ECG MONITORING ELECTRODE #4600 60MM, #4610 45MMDRXSubstantially Equivalent
K950476DISPOSABLE ECG MONITORING ELECTRODE #4440 60MM, #4420 40MMDRXSubstantially Equivalent
K90289649-610 NIKO-NOSE FIXATION TAPECBHSubstantially Equivalent
K872793DP-700 NIKMAN DEFIB-PADSLDDSubstantially Equivalent

Registered establishments

FDA registered establishments for Nikomed U.S.A., Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
22455742245574NIKOMED U.S.A., INC.2800 Turnpike Dr, Hatboro, PA 19040 US2026and 5 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

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