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

Lynge Hovedstaden, DK

WS Audiology A/S appears in FDA device records in Lynge Hovedstaden, DK. FDA records list no 510(k) clearances, no PMA records and one registered establishment. 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
0
PMA records
0
Recall records
1
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to WS Audiology A/S 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.

  • Widex A/Senforcement report, recall

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for WS Audiology A/S, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
80215143003557127WS Audiology A/SNymoellevej 6, Lynge Hovedstaden DK-3540 DK2026

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-0094-2019Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.Class IITerminated

Verification record

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