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

Franklin, IN, US

Promex, Inc. appears in FDA device records in Franklin, IN. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
18
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 18 510(k) clearances for Promex, Inc. between 1994 and 2002. The busiest year on record is 1996, with 4. The most recent is 2002, with 2.

Clearances by year, as a table
510(k) clearance decisions for Promex, Inc., by decision year
YearClearances
19942
19953
19964
19972
19991
20002
20012
20022
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K023450BIOPSY SITE TISSUE MARKER DEVICENEUSubstantially Equivalent
K022634CO-AXIAL INTRODUCER NEEDLEDYBSubstantially Equivalent
K010400VACUUM ASSISTED CORE BIOPSY DEVICEKNWSubstantially Equivalent
K011270AUTOMATED CORE BIOPSY DEVICEFCGSubstantially Equivalent
K001132BONE BIOPSY NEEDLEKNWSubstantially Equivalent
K994272AUTOMATED CORE BIOPSY DEVICEKNWSubstantially Equivalent
K993435MANUAL BONE MARROW BIOPSY DEVICEKNWSubstantially Equivalent
K973184PROSTATE SEEDING NEEDLEIWJSubstantially Equivalent
K972865PROMEX ENT TISSUE REMOVAL SYSTEMERLSubstantially Equivalent
K961078AUTOMATED VITRECTOMY DEVICEHQESubstantially Equivalent
K960023KIRSHNER WIRES (K-WIRE) & STEINMANN PINSJDWSubstantially Equivalent
K960405SPINAL NEEDLEMIASubstantially Equivalent
K955168SURGICAL CUTTERGEISubstantially Equivalent
K954265TROCAR STYLE NEEDLE/CO-AXIAL INTRODUCER NEEDLEKNWSubstantially Equivalent
K954231AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENTFCGSubstantially Equivalent
K954155GREENE, TURNER, MENGHINI STYLE ASPIRATION BIOPSY NEEDLEFCGSubstantially Equivalent
K945146CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLEFCGSubstantially Equivalent
K945124BREAST LESION LOCALIZATION NEEDLEGDFSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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