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OBP Medical Corporation

Lawrence, MA, US

OBP Medical Corporation appears in FDA device records in Lawrence, MA. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for OBP Medical Corporation in 2009.

Clearances by year, as a table
510(k) clearance decisions for OBP Medical Corporation, by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K091838OBP SELF SEALING ENDOSCOPIC SEAL WITH LUER LOCKHIHSubstantially Equivalent

Registered establishments

FDA registered establishments for OBP Medical Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30077895613007789561OBP Medical Corporation360 MERRIMACK STREET, Lawrence, MA 01843 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-2933-2026OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF: C020130-1There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the healthcare provider.Class IIOpen, Classified

Verification record

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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