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Philips Consumer Lifestyle B.V.

Drachten Fryslan, NL

Philips Consumer Lifestyle B.V. appears in FDA device records in Drachten Fryslan, NL. FDA records list 4 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
4
PMA records
0
Recall records
1
Registered establishments
3

FDA records under these names

1 name

FDA records resolved to Philips Consumer Lifestyle B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Philips Personal Health, a division of Philips North America LLCregistration

510(k) clearance history

FDA records hold 4 510(k) clearances for Philips Consumer Lifestyle B.V. between 2015 and 2025. The busiest year on record is 2015, with 2. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Philips Consumer Lifestyle B.V., by decision year
YearClearances
20152
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253754Philips Lumea IPLOHTSubstantially Equivalent
K243453Philips Lumea IPLOHTSubstantially Equivalent
K151033Philips Self-Adhesive ElectrodesGXYSubstantially Equivalent
K151035PulseReliefNUHSubstantially Equivalent

Registered establishments

FDA registered establishments for Philips Consumer Lifestyle B.V., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30076011643007601164Philips Consumer Lifestyle B.V.Oliemolenstraat 5, Drachten Fryslan 9203 ZN NL2026
30103592223010359222Philips Consumer Lifestyle B.V.Tussendiepen 4, Drachten Fryslan 9206AD NL2026
30091815613009181561Philips Personal Health, a division of Philips North America LLC1055 Washington Blvd., Stamford, CT 06901 US2026No device listings on this registration

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0689-2018Philips Avent Smart Ear Thermometer (SCH740), Philips Ear Thermometer (DL8740)Device may provide inaccurate measurements.Class IITerminated

Verification record

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