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

Jefferson, MD, US

BIOELECTRONICS CORPORATION appears in FDA device records in Jefferson, MD. FDA records list 3 510(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
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Bioelectronics Corporation between 2017 and 2020. The busiest year on record is 2017, with 1. The most recent is 2020, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bioelectronics Corporation, by decision year
YearClearances
20171
20191
20201
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K192234ActiPatchPQYSubstantially Equivalent
K190251RecoveryRxILXSubstantially Equivalent
K152432ActiPatch(R)PQYSubstantially Equivalent

Registered establishments

FDA registered establishments for Bioelectronics Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30048377023005550216BIOELECTRONICS CORPORATION3880 Roundtree Rd Unit 1, Jefferson, MD 21755 US2026

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

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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What MDM checks, and what it does not

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