510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

BSG Corp

Acton, MA, US

BSG Corp appears in FDA device records in Acton, MA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to BSG Corp 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.

  • Bio-Signal Group Corporation510(k), enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for BSG Corp in 2012.

Clearances by year, as a table
510(k) clearance decisions for BSG Corp, by decision year
YearClearances
20121
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K112817MICROEEG SYSTEMGWQSubstantially Equivalent

Registered establishments

FDA registered establishments for BSG Corp, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30063152743006315274BSG Corp3 Post Office Square, Acton, MA 01720 US2026

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-0705-2020HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)Class IITerminated
Z-0704-2020HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)Class IITerminated

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.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets BSG Corp edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

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