Medical Device
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Sscor, Inc.

Simi Valley, CA, US

SSCOR, INC. appears in FDA device records in Simi Valley, CA. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 6 recalls 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
6
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Sscor, Inc. 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.

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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 Sscor, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
20227242022724SSCOR, INC.2125 N. Madera Rd Unit C, Simi Valley, CA 93065 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-0416-05SSCOR Suction Device Model 2315Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.Terminated
Z-0415-05SSCOR Suction Device Model 2314BReports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.Terminated
Z-0414-05SSCOR Suction Device Model 2314Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.Terminated
Z-0413-05SSCOR Suction Device Model 2310BV-230Reports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.Terminated
Z-0412-05SSCOR Suction Device Model 2310VReports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.Terminated
Z-0411-05SSCOR Suction Device Model 2310BVReports from medical professionals that SSCOR suction device has not performed as intended. Firm's investigation disclosed that the condition in questions is caused by cracked regulators that result in inadequate suction.Terminated

Verification record

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