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

Kentwood, MI, US

Inrad appears in FDA device records in Kentwood, MI. FDA records list 14 510(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
14
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 14 510(k) clearances for Inrad between 1998 and 2025. The busiest year on record is 1998, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Inrad, by decision year
YearClearances
19983
20002
20042
20071
20093
20191
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243886ExpressCore Biopsy DeviceKNWSubstantially Equivalent
K240429Trilogy Tissue MarkerNEUSubstantially Equivalent
K183503EasyMark Tissue MarkerNEUSubstantially Equivalent
K093399PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520KNWSubstantially Equivalent
K093256SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018KNWSubstantially Equivalent
K090611REVOLUTION FULL CORE BIOPSYKNWSubstantially Equivalent
K063238ULTRACLIP II WING AND ULTRACLIP II COILNEUSubstantially Equivalent
K042341ULTRACLIP II USNEUSubstantially Equivalent
K041201ULTRACLIP II MRGDWSubstantially Equivalent
K000612ACCUCORE SINGLE ACTION CORE BIOPSY DEVICEKNWSubstantially Equivalent
K993785ULTRACLIP TISSUE MARKERGDWSubstantially Equivalent
K981721C0-AXIAL INTRODUCER NEEDLEKNWSubstantially Equivalent
K981166ACCUCORE CORE BIOPSY NEEDLE CATALOG CODES:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214KNWSubstantially Equivalent
K980587IV DECANTER-FLEXIBLELHISubstantially 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

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.

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