510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Primed Instruments, Inc.

MISSISSAUGA Ontario, CA

PRIMED INSTRUMENTS, INC. appears in FDA device records in MISSISSAUGA Ontario, CA. FDA records list one 510(k) clearance, 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
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Primed Instruments, Inc. in 1993.

Clearances by year, as a table
510(k) clearance decisions for Primed Instruments, Inc., by decision year
YearClearances
19931
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K934186FORCEPS, BIOPSY, GASTROINTESTINALFCLSubstantially Equivalent

Registered establishments

FDA registered establishments for Primed Instruments, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96804883002642300PRIMED INSTRUMENTS, INC.1080 TRISTAR DR., UNIT 11, 13 & 14, MISSISSAUGA Ontario L5T 1P1 CA2026

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