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

Askim Vastra Gotaland, SE

Oticon Medical AB appears in FDA device records in Askim Vastra Gotaland, SE. FDA records list 16 510(k) clearances between and , 14 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
16
PMA records
14
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Oticon Medical AB between 2008 and 2024. The busiest year on record is 2021, with 3. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Oticon Medical AB, by decision year
YearClearances
20081
20091
20112
20121
20131
20141
20152
20162
20191
20213
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSPFOSubstantially Equivalent
K213733Ponto 5 SuperPowerLXBSubstantially Equivalent
K211640Ponto 5 MiniLXBSubstantially Equivalent
K203807Ponto Bone Anchored Hearing System, MONO Surgery KitMAHSubstantially Equivalent
K190540Ponto 4LXBSubstantially Equivalent
K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerLXBSubstantially Equivalent
K152820Ponto Bone Anchored Hearing SystemMAHSubstantially Equivalent
K152067Ponto bone anchored hearing systemMAHSubstantially Equivalent
K142678Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mmMAHSubstantially Equivalent
K141616STERILIZATION CASSETTEKCTSubstantially Equivalent
K132775PONTO PLUS AND PONTO PLUS POWERLXBSubstantially Equivalent
K121228PONTO BONE ANCHORED HEARING SYSTEMMAHSubstantially Equivalent
K112053OBC BONE ANCHORED HEARING SYSTEMMAHSubstantially Equivalent
K103594PONTO PRO POWERLXBSubstantially Equivalent
K090996PONTO PROLXBSubstantially Equivalent
K082108OBC BONE ANCHORED HEARING AID SYSTEMLXBSubstantially Equivalent

Registered establishments

FDA registered establishments for Oticon Medical AB, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30073677323007367732Oticon Medical ABDatavagen 37B, Askim Vastra Gotaland 43632 SE2026

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